#Crenolanib

[amcrasto]

CRENOLANIB

Crenolanib Molecular FormulaC26H29N5O2Average mass443.541 Da 1-(2-{5-[(3-Methyl-3-oxetanyl)methoxy]-1H-benzimidazol-1-yl}-8-quinolinyl)-4-piperidinamine 1-(2-{5-[(3-methyloxetan-3-yl)methoxy]-1H-benzimidazol-1-yl}quinolin-8-yl)piperidin-4-amine 1-[2-[5-[(3-methyl-3-oxetanyl)methoxy]-1H-benzimidazol-1-yl]-8-quinolinyl]-4-piperidinamine 4-Piperidinamine,…

[pharmaphorumuk]

Astellas gets EU approval for AML drug Xospata

The European Commission has approved Astellas’ Xospata (gilteritinib) for patients with relapsed or refractory FLT3-positive acute myeloid leukemia (AML), cementing its lead over a rival drug from Daiichi Sankyo.

Xospata, a FLT3 inhibitor, received an accelerated review, and the approval follows a positive CHMP recommendation in September.

The FLT3 mutation is expressed in about 30% of AML patients and is associated with a worse prognosis, higher relapse rate, faster progression and shorter overall survival, and FLT3 inhibitors have been pitched as a major advance in treatment for patients.

Xospata has been shown in the ADMIRAL clinical trial to improve overall survival compared to salvage chemotherapy, the standard second-line treatment option, with a median OS of 9.3 months for the Astellas drug versus 5.6 months for chemo.

It has been shown to work in two FLT3 mutations – namely ITD and TKD – while quizartinib only targets ITD but has greater potency against that target.

“AML is a rare cancer and patients with a FLT3 mutation have a particularly poor prognosis, with a median survival of less than six months following treatment with salvage chemotherapy,” said Giovanni Martinelli, an investigator in the ADMIRAL trial. “Gilteritinib is a new and clinically meaningful treatment option that provides a welcome advance for patients and health care professionals across the European Union.”

Xospata was cleared in the US and Japan last year, and the CHMP backing gives Astellas another leg up in the market over Daiichi Sankyo and its FLT3 inhibitor quizartinib.

The EMA is also in the midst of an accelerated review of quizartinib, but Daiichi Sankyo suffered a big setback last year when the FDA rejected its marketing application, just a few days after it claimed its first approval in Japan. The FDA verdict came after its advisory committee voted against the drug on the grounds that the clinical trial data in its marketing application may not be reliable.

Xospata and quizartinib have reached the market after Novartis’ first-to-market FLT3-targeting drug Rydapt (midostaurin), which was approved in both the US and Europe for newly-diagnosed FLT3-positive AML in combination with chemotherapy in 2017.

Astellas and Daiichi Sankyo’s drugs are being positioned initially as second-generation FLT3 inhibitors that build on the activity seen with Rydapt and extend the use of the class into second-line treatment.

However, both companies have aspirations to extend their use into the first-line setting and challenge Rydapt directly. There’s also more potential competition on the way from AROG Pharma, whose FLT3 inhibitor crenolanib is in late-stage development for newly-diagnosed as well as relapsed/refractory AML.

Sales of Novartis’ drug are too small to warrant their own line in the company’s quarterly results statements, but analysts have previously suggested that peak sales of the drug will be in the $250 to $300 million range.

Astellas reported sales of around $22 million for Xospata in the first quarter of fiscal 2019, and has said it expects that to increase to around $140m for the full-year.

The post Astellas gets EU approval for AML drug Xospata appeared first on .

from https://pharmaphorum.com/news/astellas-gets-eu-approval-for-aml-drug-xospata/

[kritikarehani]

Soft Tissue Sarcoma Market Analysis, Market Growth and Industry Analysis

DelveInsight’s launched a new report on “Soft Tissue Sarcoma Market Insights, Epidemiology, and Market Forecast-2030”. The report deliver an in-depth understanding of the disease, historical & forecasted epidemiology as well as the market trends of Soft Tissue Sarcoma (STS) in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.  

The Soft Tissue Sarcoma market report provides analysis regarding current treatment practices, emerging drugs like AL3818, Fibromun, AL3818, Ripretinib, market share of the individual therapies, historical, current and forecasted Soft Tissue Sarcoma market Size from 2017 to 2030 segmented by seven major markets.

Soft Tissue Sarcoma

Soft Tissue Sarcoma Overview

Soft-tissue sarcoma are rare neoplasms that can develop in supporting or connective tissue, such as the muscle, nerves, tendons, blood vessels, and fatty and fibrous tissues. They commonly affect the arms, legs, and trunk. They also appear in the stomach and intestines (GIST) as well as behind the abdomen (retroperitoneal sarcomas) and the female reproductive system (gynecological sarcomas). STSs may be classified according to the involved cell-type, the specific nature of the malignancy, and the disease’s clinical course.

According to the World Health Organization (WHO), there are more than 50 histologic subtypes of STSs. The signs and symptoms of STSs vary greatly from patients to patients based on the type of STS. However, it is not associated with any noticeable symptoms early in the course of the disease, but the affected individuals may notice slow-growing, painless mass in the affected area.

Soft Tissue Sarcoma Treatment 

This chapter covers the details of conventional and current medical therapies available in the Soft tissue sarcoma market for the treatment of the condition. It also provides the country-wise Soft Tissue Sarcoma treatment guidelines and algorithm across the United States, Europe and Japan. 

DelveInsight’s Soft tissue sarcoma market report gives a thorough understanding of the disease by including details such as disease definition, symptoms, causes, pathophysiology, and diagnosis. It also provides Soft tissue sarcoma treatment algorithms and treatment guidelines in the US, Europe, and Japan.

Soft Tissue Sarcoma Epidemiology

Soft Tissue Sarcoma has various subtypes. It was observed that in the United States and European countries, liposarcoma and leiomyosarcoma were the most incident subtypes of STS, which contributed to the majority of the cases. Whereas in Japan, subtypes, fibroblastic sarcomas and liposarcoma were more common.

According to DelveInsight’s, the total Soft Tissue Sarcoma incident population in seven major markets was 40,155 in 2017. These cases are expected to increase with a significant CAGR during the study period (2017–2030).

Among all the seven major markets, the United States accounts for the highest number of Soft Tissue Sarcoma cases. In 2017, there were 12,390 incident cases of STS—which did not include GIST cases—in the United States. The total incident cases of GIST which were observed in the United States in 2017 accounted for 5,090. This lead to the total Soft Tissue Sarcoma incident population to 17,480 in 2017.

Soft Tissue Sarcoma Drug Chapters

Drug chapter segment of the Soft Tissue Sarcoma report encloses the detailed analysis of Soft Tissue Sarcoma marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the Soft Tissue Sarcoma clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.

The report provides the details of the emerging therapies under the late and mid-stage of development for Soft Tissue Sarcoma treatment and marketed product available for Soft Tissue Sarcoma treatment.

STS primarily encountered in adults but can affect patients of any age. There are many histologic subtypes, and the malignancy can be low or high grade. Soft tissue sarcoma treatments may include surgery, chemotherapy, radiation therapy, or a combination of these therapies.

The emerging therapies are classified into four categories based on their line of therapy. The upcoming first-line therapies that are going to be launched in the forecasted period includes, AL3818 (anlotinib) and Fibromun. The second-line emerging therapies include Vigil in combination with irinotecan and temozolomide, AL3818, GSK 3377794, Ripretinib (DCC-2618), Tazemetostat, Abemaciclib, Pembrolizumab, Crizotinib, ABI-009, and SRA737. The third-line emerging therapies include Avapritinib, Cabozantinib, and Selinexor. The fourth-line emerging therapies include Avapritinib, TAS-116, Crenolanib, and Ripretinib.

Soft Tissue Sarcoma Market Outlook

The Soft Tissue Sarcoma market size is expected to increase at a significant CAGR during the study period (2017–2030). Among all the seven major markets, the United States accounts for the highest Soft Tissue Sarcoma market size. Among EU5, Germany had the highest Soft Tissue Sarcoma market size in 2017 USD 22.06 million, followed by Italy. The market size of STS (excluding GIST) in Japan was found to be least in 2017.

The key companies involved for Soft Tissue Sarcoma market treatment are Amgen, BioPharma, AstraZeneca and many others.

Soft Tissue Sarcoma Drugs Uptake

The current Soft Tissue Sarcoma market size is mainly attributed to Votrient, Yondelis, Halaven, and various anthracycline and non-anthracycline regimens. The market size of GIST in the United States was found to be USD 119.7 million in 2017 and expected to increase during the forecast period (2020–2030) due to potential therapies Vitrakvi, Rozlytrek, Avapritinib, Ripretinib and others.    

View full report @https://www.delveinsight.com/report-store/soft-tissue-sarcoma-market

Frequently asked questions:

At what CAGR, Soft Tissue Sarcoma market is expected to grow for the study period 2017-30?

The Soft Tissue Sarcoma market is expected to increase at a CAGR of 6.47% during forecast period (2017-2030). 

Which geography accounted for the largest Soft Tissue Sarcoma market size?

United States accounted for the largest Soft Tissue Sarcoma market size.

What is forecasted soft tissue sarcoma market size in 2030?

DelveInsight estimates an increase in STS Market Size during the study period, 2017–2030

What are the present Soft Tissue Sarcoma market drivers?

Competitive Landscape, Precision Medicine Approach & Novel Therapies for Subtype of STS.

What are the Soft Tissue Sarcoma market barriers?

High Cost of Treatment, Stringent Government Regulations & High Failure Rate in the Clinical Trials.

How many companies are developing drugs for soft tissue sarcoma?

Currently more than 8 companies are developing drugs for soft tissue sarcoma.

Which are the leading companies in soft tissue sarcoma market?

Key Companies - Bayer, Gradalis, Karyopharm, Novartis, Eli Lilly, GlaxoSmithKline, Merck Sharp& Dohme Corp. and several others.

How is epidemiology segmented for soft tissue sarcoma?

Total Incident Cases of STS in the 7MM, Gender-Specific Incidence of STS in the 7MM, Gender-Specific Incidence of STS in the 7MM, Incidence of STS by Extremities (%) in the 7MM, Stage-Specific Incidence of STS in the 7MM and Age-Specific Incidence of STS in the 7MM.

Request for free sample pages: https://www.delveinsight.com/sample-request/soft-tissue-sarcoma-market

[investorshangout]

News: Arog Pharmaceuticals Announces Clinical Presentations on Crenolanib at the 23rd Congress of the Euro

https://investorshangout.com/post/view?id=5077170&utm_source=dlvr.it&utm_medium=tumblr

[sisiad]

CAR T-cells targeting FLT3 have potent activity against FLT3−ITD+AML and act synergistically with the FLT3-inhibitor crenolanib

http://dlvr.it/QF9RML

[medipaper]

via MediNews

[cancersfakianakis1]

Succinate dehydrogenase deficiency in a PDGFRA mutated GIST

Abstract

Background

Most gastrointestinal stromal tumors (GISTs) harbor mutually exclusive gain of function mutations in the receptor tyrosine kinase (RTK) KIT (70–80%) or in the related receptor PDGFRA (~10%). These GISTs generally respond well to therapy with the RTK inhibitor imatinib mesylate (IM), although initial response is genotype-dependent. An alternate mechanism leading to GIST oncogenesis is deficiency in the succinate dehydrogenase (SDH) enzyme complex resulting from genetic or epigenetic inactivation of one of the four SDH subunit genes (SDHA, SDHB, SDHC, SDHD, collectively referred to as SDHX). SDH loss of function is generally seen only in GIST lacking RTK mutations, and SDH-deficient GIST respond poorly to imatinib therapy.

Methods

Tumor and normal DNA from a GIST case carrying the IM-resistant PDGFRA D842V mutation was analyzed by whole exome sequencing (WES) to identify additional potential targets for therapy. The tumors analyzed were separate recurrences following progression on imatinib, sunitinib, and the experimental PDGFRA inhibitor crenolanib. Tumor sections from the GIST case and a panel of ~75 additional GISTs were subjected to immunohistochemistry (IHC) for the SDHB subunit.

Results

Surprisingly, a somatic, loss of function mutation in exon 4 of the SDHB subunit gene (c.291_292delCT, p.I97Mfs*21) was identified in both tumors. Sanger sequencing confirmed the presence of this inactivating mutation, and IHC for the SDHB subunit demonstrated that these tumors were SDH-deficient. IHC for the SDHB subunit across a panel of ~75 GIST cases failed to detect SDH deficiency in other GISTs with RTK mutations.

Conclusions

This is the first reported case of a PDGFRA mutant GIST exhibiting SDH-deficiency. A brief discussion of the relevant GIST literature is included.

http://ift.tt/2v0jZnz

[pharmaphorumuk]

Astellas maintains lead over Daiichi Sankyo with CHMP okay for Xospata

Astellas’ FLT3 inhibitor for acute myeloid leukaemia (AML) – Xospata – has been recommended for approval in Europe, giving it a further lead over a rival drug from Daiichi Sankyo.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Xospata (gilteritinib) as a treatment for adult patients with relapsed or refractory FLT3-positive AML at its meeting late last week, after an accelerated review.

The green light means that EMA approval is likely to follow within the next few weeks, and would be “one of the few advances for the treatment of AML in Europe over the past 40 years,” according to Astellas.

Xospata was cleared in the US and Japan last year, and the CHMP backing gives Astellas another leg up in the market over Daiichi Sankyo and its FLT3 inhibitor quizartinib.

The EMA is also in the midst of an accelerated review of quizartinib, but Daiichi Sankyo suffered a big setback last year when the FDA rejected its marketing application, just a few days after it claimed its first approval in Japan. The FDA verdict came after its advisory committee voted against the drug on the grounds that the clinical trial data in its marketing application may not be reliable.

The FLT3 mutation is expressed in about 30% of AML patients and is associated with a worse prognosis, higher relapse rate, faster progression and shorter overall survival, and FLT3 inhibitors have been pitched as a major advance in treatment for patients.

Xospata has been shown in the ADMIRAL clinical trial to improve overall survival compared to salvage chemotherapy, the standard second-line treatment option, with a median OS of 9.3 months for Astellas drug versus 5.6 months for chemo.

It has been shown to work in two FLT3 mutations – namely ITD and TKD – while quizartinib only targets ITD but has greater potency against that target.

Xospata and quizartinib have reached the market after Novartis’ first-to-market FLT3-targeting drug Rydapt (midostaurin), which was approved in both the US and Europe for newly-diagnosed FLT3-positive AML in combination with chemotherapy in 2017.

Astellas and Daiichi Sankyo’s drugs are being positioned initially as second-generation FLT3 inhibitors that build on the activity seen with Rydapt and extend the use of the class into second-line treatment.

However, both companies have aspirations to extend their use into the first-line setting and challenge Rydapt directly. There’s also more potential competition on the way from Arog Pharma, whose FLT3 inhibitor crenolanib is in late-stage development for newly-diagnosed as well as relapsed/refractory AML.

Sales of Novartis’ drug are too small to warrant their own line in the company’s quarterly results statements, but analysts have previously suggested that peak sales of the drug will be in the $250 to $300 million range.

Astellas reported sales of around $22 million for Xospata in the first quarter of fiscal 2019, and has said it expects that to increase to around $140m for the full-year.

The post Astellas maintains lead over Daiichi Sankyo with CHMP okay for Xospata appeared first on Pharmaphorum.

from Pharmaphorum https://pharmaphorum.com/news/astellas-maintains-lead-over-daiichi-sankyo-with-aml-drug-xospata/

[healthy-insights]

Glioblastoma Treatment Market: Emergence of Advanced Technologies & Global Industry Analysis 2022!!

A new Transparency Market Research report states that the global glioblastoma treatment market stood at US$0.34 bn in 2013 and is predicted to reach US$0.91 bn in 2022. It is predicted to expand at a CAGR of 11.40% from 2014 to 2022. The title of the report is “Glioblastoma Multiforme Treatment (GBM) Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 - 2022.”

Browse the full Pipeline Review of Glioblastoma Treatment Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 - 2022 report at http://www.transparencymarketresearch.com/pipeline-review-of-glioblastoma-treatment-market.html

According to the report, the increasing aging population globally is fuelling the market for glioblastoma multiforme treatment. In addition, a number of non-government and government organizations are taking several steps to increase awareness on GBM, hence boosting the market. Furthermore, it has been predicted that the introduction of a number of novel therapies in the coming years will also augment the growth of the market for glioblastoma multiforme treatment in forthcoming years. On the other hand, the present survival period of drugs approved by the FDA for the treatment of glioblastoma multiforme is less and this is a key factor restraining the growth of the market. In addition, currently available therapies have limitations owing to GBM being immensely resistant to DNA modifying agents. This may also pose a negative impact on the growth of the market.

On the basis of drug, the market for glioblastoma multiforme treatment is segmented into bevacizumab (avastin), carmustine (bicnu), and temozolomide (temodar, temodal, and temcad). Amongst these, in 2013, temozolomide took the largest share in the market owing to its great effectiveness. On the other hand, bevacizumab (avastin) is the latest addition to the string of drugs and is the first monoclonal antibody drug passed for the treatment of GBM. This drug is relatively more effective as compared to temozolomide and is predicted to hold the largest share in the market on the basis of revenue by the end of 2016.

The pipeline review of glioblastoma multiforme treatment includes a number of drugs in preclinical phase, phase I, phase II, and phase III. Drugs under preclinical, stage I and stage II include ABT-414, MM-398, ARC-100, AV0113, Cotara, Crenolanib, SGT-53, Endostatin, and ANG1005. Drugs under phase II include rindopepimut (CDX-110), DCVax, and others.

Download Exclusive Brochure of This Report :

http://www.transparencymarketresearch.com/sample/sample.php?flag=B&rep_id=4807

In terms of geography, the report segments the market into North America, Asia Pacific, Europe, and Rest of the World (RoW). Amongst these, North America led the market for glioblastoma multiforme treatment in 2013 owing to the increasing public awareness because of support from non-government and government organizations. In addition, the developed healthcare infrastructure in this region has also augmented the growth of the market. On the other hand, the region of Asia Pacific is the most rapidly growing glioblastoma multiforme treatment market owing to the advanced healthcare infrastructure and the increasing awareness about GBM within this region.

As per the report, the chief players operating in the market are Abbvie, Inc., Celldex Therapeutics, Inc., Exellixis, Inc., Brostol-Myers Squibb Co. and F. Hoffman-La Roche.

The pipeline review of glioblastoma treatment market has been segmented as below:

Global Glioblastoma Treatment Market Revenue and Forecast, by Drugs

Global Glioblastoma Treatment Market Revenue and Forecast, by Geography

Global Pipeline Review of Glioblastoma Treatment

Bevacizumab (Avastin)

Temozolomide (Temodar and Temodal and Temcad)

Carmustine (BiCNU)

North America

Europe

Asia Pacific

Rest of the World

Overview

Late Stage (Phase III)

Early Stage (Phase I, II and Pre clinical)

Others

DCVax

Rindopepimut (CDX-110)

Others

ABT-414

MM-398

ARC-100

AV0113

Cotara

Crenolanib

SGT-53

Endostatin

ANG1005

About Us

Transparency Market Research (TMR) is a global market intelligence company providing business information reports and services. The company’s exclusive blend of quantitative forecasting and trend analysis provides forward-looking insight for thousands of decision makers. TMR’s experienced team of analysts, researchers, and consultants use proprietary data sources and various tools and techniques to gather and analyze information.

TMR’s data repository is continuously updated and revised by a team of research experts so that it always reflects the latest trends and information. With extensive research and analysis capabilities, Transparency Market Research employs rigorous primary and secondary research techniques to develop distinctive data sets and research material for business reports.

Contact

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[kritikarehani]

Soft Tissue Sarcoma Market Size and Share | Soft Tissue Sarcoma | DelveInsight

DelveInsight’s ‘Soft Tissue Sarcoma Market Insights, Epidemiology, and Market Forecast-2030’ report deliver an in-depth understanding of the disease, historical & forecasted epidemiology as well as the market trends of Soft Tissue Sarcoma (STS) in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.  

The Soft Tissue Sarcoma market report provides analysis regarding current treatment practices, emerging drugs like AL3818, Fibromun, AL3818, Ripretinib, market share of the individual therapies, historical, current and forecasted Soft Tissue Sarcoma market Size from 2017 to 2030 segmented by seven major markets.

The Report also covers current Soft Tissue Sarcoma treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate best of the opportunities and assesses underlying potential of the market.

Geography Covered

·         The United States

·          EU5 (Germany, France, Italy, Spain, and the United Kingdom)

·          Japan

Soft Tissue Sarcoma - Disease Understanding and Treatment Algorithm

Soft Tissue Sarcoma Overview

Soft-tissue sarcoma are rare neoplasms that can develop in supporting or connective tissue, such as the muscle, nerves, tendons, blood vessels, and fatty and fibrous tissues. They commonly affect the arms, legs, and trunk. They also appear in the stomach and intestines (GIST) as well as behind the abdomen (retroperitoneal sarcomas) and the female reproductive system (gynecological sarcomas). STSs may be classified according to the involved cell-type, the specific nature of the malignancy, and the disease’s clinical course.

According to the World Health Organization (WHO), there are more than 50 histologic subtypes of STSs. The signs and symptoms of STSs vary greatly from patients to patients based on the type of STS. However, it is not associated with any noticeable symptoms early in the course of the disease, but the affected individuals may notice slow-growing, painless mass in the affected area.

Soft Tissue Sarcoma Treatment 

This chapter covers the details of conventional and current medical therapies available in the Soft tissue sarcoma market for the treatment of the condition. It also provides the country-wise Soft Tissue Sarcoma treatment guidelines and algorithm across the United States, Europe and Japan. 

DelveInsight’s Soft tissue sarcoma market report gives a thorough understanding of the disease by including details such as disease definition, symptoms, causes, pathophysiology, and diagnosis. It also provides Soft tissue sarcoma treatment algorithms and treatment guidelines in the US, Europe, and Japan.

Soft Tissue Sarcoma Epidemiology

The Soft Tissue Sarcoma epidemiology chapters provide insights about historical and current Soft Tissue Sarcoma patient pool and forecasted trend for every seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. Soft tissue sarcoma epidemiology is segmented by gender-specific incidence, type-specific incidence, age-specific, stage-specific, and extremities. The report includes thorough analysis of all segmentations.

Soft Tissue Sarcoma has various subtypes. It was observed that in the United States and European countries, liposarcoma and leiomyosarcoma were the most incident subtypes of STS, which contributed to the majority of the cases. Whereas in Japan, subtypes, fibroblastic sarcomas and liposarcoma were more common.

According to DelveInsight’s, the total Soft Tissue Sarcoma incident population in seven major markets was 40,155 in 2017. These cases are expected to increase with a significant CAGR during the study period (2017–2030).

Among all the seven major markets, the United States accounts for the highest number of Soft Tissue Sarcoma cases. In 2017, there were 12,390 incident cases of STS—which did not include GIST cases—in the United States. The total incident cases of GIST which were observed in the United States in 2017 accounted for 5,090. This lead to the total Soft Tissue Sarcoma incident population to 17,480 in 2017.

Soft Tissue Sarcoma Drug Chapters

Drug chapter segment of the Soft Tissue Sarcoma report encloses the detailed analysis of Soft Tissue Sarcoma marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the Soft Tissue Sarcoma clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.

The report provides the details of the emerging therapies under the late and mid-stage of development for Soft Tissue Sarcoma treatment and marketed product available for Soft Tissue Sarcoma treatment.

STS primarily encountered in adults but can affect patients of any age. There are many histologic subtypes, and the malignancy can be low or high grade. Soft tissue sarcoma treatments may include surgery, chemotherapy, radiation therapy, or a combination of these therapies.

The emerging therapies are classified into four categories based on their line of therapy. The upcoming first-line therapies that are going to be launched in the forecasted period includes, AL3818 (anlotinib) and Fibromun. The second-line emerging therapies include Vigil in combination with irinotecan and temozolomide, AL3818, GSK 3377794, Ripretinib (DCC-2618), Tazemetostat, Abemaciclib, Pembrolizumab, Crizotinib, ABI-009, and SRA737. The third-line emerging therapies include Avapritinib, Cabozantinib, and Selinexor. The fourth-line emerging therapies include Avapritinib, TAS-116, Crenolanib, and Ripretinib.

Soft Tissue Sarcoma Market Outlook

The Soft Tissue Sarcoma market size is expected to increase at a significant CAGR during the study period (2017–2030). Among all the seven major markets, the United States accounts for the highest Soft Tissue Sarcoma market size. Among EU5, Germany had the highest Soft Tissue Sarcoma market size in 2017 USD 22.06 million, followed by Italy. The market size of STS (excluding GIST) in Japan was found to be least in 2017.

The key companies involved for Soft Tissue Sarcoma market treatment are Amgen, BioPharma, AstraZeneca and many others.

Soft Tissue Sarcoma Drugs Uptake

This section focusses on the rate of uptake of the potential drugs recently launched in the Soft Tissue Sarcoma market or expected to get launched in the market during the study period 2017-2030. The analysis covers Soft Tissue Sarcoma market uptake by drugs; patient uptake by therapies; and sales of each drug.

This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs and allow the comparison of the drugs on the basis of market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

The current Soft Tissue Sarcoma market size is mainly attributed to Votrient, Yondelis, Halaven, and various anthracycline and non-anthracycline regimens. The market size of GIST in the United States was found to be USD 119.7 million in 2017 and expected to increase during the forecast period (2020–2030) due to potential therapies Vitrakvi, Rozlytrek, Avapritinib, Ripretinib and others.    

Report Highlights

· In the coming years, Soft Tissue Sarcoma market is set to change due to the rising awareness of the disease, and incremental healthcare spending across the world; which would expand the Soft Tissue Sarcoma market size to enable the drug manufacturers to penetrate more into the market

· Major players like Blueprint Medicines Corporation, Gradalis, Karyopharm Therapeutics and many others are involved in developing therapies for Soft Tissue Sarcoma. Launch of emerging therapies will significantly impact the Soft Tissue Sarcoma market

· A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for Soft Tissue Sarcoma

· Our in-depth analysis of the pipeline assets across different stages of development (Phase III and Phase II), different emerging trends and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities

Soft Tissue Sarcoma Report Insights

· Patient Population

· Therapeutic Approaches

· Soft Tissue Sarcoma Pipeline Analysis

· Soft Tissue Sarcoma Market Size and Trends

· Market Opportunities

· Impact of upcoming Therapies

Download a free sample report on Soft Tissue Sarcoma:

https://www.delveinsight.com/report-store/soft-tissue-sarcoma-market

[medipaper]

via MediNews

[pharmaphorumuk]

Daiichi Sankyo claims speedy review for AML drug in Europe

Japan’s Daiichi Sankyo is looking at a reduced review time for its acute myeloid leukaemia (AML) drug quizartinib in Europe, the top prospect in its new oncology pipeline.

The European Medicines Agency (EMA) has given the nod to an accelerated assessment for quizartinib – a second-generation FLT3 inhibitor – as a second-line therapy for adult AML patients with FLT3-ITD mutations, a particularly aggressive form of the cancer. It’s also started its review of the drug which means quizartinib could get a green light around the middle of next year.

If approved, quizartinib will join Novartis’ Rydapt (midostaurin),  which is currently the only FLT3 inhibitor on the market and was cleared by the US and EU regulators for newly-diagnosed FLT3-positive AML last year.

Rydapt’s effects are modest however, and quizartinib is one of a handful of second-generation FLT3 inhibitors that aim to provide a second-line of therapy for patients with relapsed or refractory FLT3-ITD-positive AML – a group for which there are currently no approved options. Along with the EU, quizartinib has also been submitted for approval in Japan – where it is also under accelerated review – and should be filed in the US before the end of the year. The FDA has awarded the drug breakthrough status.

Quizartinib’s marketing applications are backed by the QuANTUM-R trial, which showed that the drug prolonged overall survival as an oral, single agent compared to salvage chemotherapy in adults with relapsed/refractory FLT3-ITD AML. Daiichi Sankyo says its drug is the first in its class to do achieve that objective in this setting.

Daiichi Sankyo isn’t the only company hoping to improve on Rydapt with second-generation drugs however. Astellas recently filed for approval of its FLT3 inhibitor gilteritinib in relapsed FLT3-positive AML in the US, while AROG Pharma recently started two phase III trials ongoing for its candidate crenolanib, including a head-to-head study against Rydapt in the first-line setting.

Arnaud Lesegretain, Daiichi Sankyo’s vice president, oncology R&D, said that the EU accelerated assessment “underscores the significant unmet need for patients with relapsed/refractory FLT3-ITD AML.”

It’s also another step on the path to developing a new oncology franchise at Daiichi Sankyo, a move it started several years ago. Quizartinib was added to its pipeline in 2014 when the company bought Ambit Biosciences for $410 million.

Some of its other programmes have suffered setbacks, however, including EGFR-targeted antibody nimotuzumab which was in development for non-small cell lung cancer (NSCLC) but was pulled because of toxicity issues, and HER3 inhibitor patritumab which failed a combination study with Roche’s EGFR drug Tarceva (erlotinib) in the same cancer. The company has also racked up a few failed trials for ArQule-partnered MET inhibitor tivantinib and dropped it in 2017.

Along with quizartinib, Daiichi Sankyo’s late-stage pipeline projects in cancer are CSF-1R/KIT/FLT3 inhibitor pexidartinib for tenosynovial giant cell tumours and Amgen-partnered anti-RANKL antibody denosumab for breast cancer, which is being developed for the Japanese market only.

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