#Ripretinib

[newswireml]

Analysis of ctDNA Pinpoints Responders to Second-Line GIST Therapy#Analysis #ctDNA #Pinpoints #Responders #SecondLine #GIST #Therapy

Circulating tumor DNA (ctDNA) analysis of KIT mutational status may be able to guide second-line treatment in patients with imatinib-resistant gastrointestinal stromal tumors (GIST), according to an exploratory analysis from the INTRIGUE trial. Specifically, patients with KIT exon 11 plus 17/18 (activation loop) mutations had superior responses and better survival outcomes with ripretinib…

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Ripretinib (Mechanism of Action)

Ripretinib (Mechanism of Action)

In this article, we will discuss Ripretinib (Mechanism of Action). So, let’s get started. Mechanism of ActionRipretinib is a tyrosine kinase inhibitor that inhibits KIT proto-oncogene receptor tyrosine kinase (KIT) and platelet derived growth factor receptor A (PDGFRA) kinase, including wild type, primary, and secondary mutations. Ripretinib also inhibits other kinases in vitro, such as PDGFRB,…

[sharonsmith731]

Ripretinib Safer Than Sunitinib for GIST, Fails to Improve PFS

The findings suggest that ripretinib (Qinlock) provides a similar PFS benefit but may come with notably better tolerability compared with sunitinib. Medscape Medical News from Medscape Medical News Headlines https://www.medscape.com/viewarticle/967401?src=rss

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تمت الموافقة على Qinlock كعلاج الخط الرابع لـ GIST

الاثنين ، 18 مايو 2020 (HealthDay News) – وافقت إدارة الغذاء والدواء الأمريكية على أقراص Qinlock (ripretinib) كعلاج للخط الرابع للبالغين الذين يعانون من أورام انسجة الجهاز الهضمي المتقدمة (GISTs) ، حسبما أعلنت الوكالة يوم الجمعة.

تأتي الموافقة بعد أربعة علاجات مستهدفة معتمدة من قِبل إدارة الأغذية والعقاقير لـ GIST ، بما في ذلك imatinib في عام 2002 و sunitinib في عام 2006 و regorafenib في عام 2013 و avapritinib في يناير. يشار Qinlock للمرضى الذين تلقوا على الأقل ثلاث علاجات مثبطات كيناز ، بما في ذلك imatinib.

اعتمدت الموافقة على Qinlock على بيانات من تجربة سريرية دولية متعددة المراكز ، عشوائية ، مزدوجة التعمية ، يتم التحكم فيها بالغفل مع 129 مريضًا يعانون من GIST المتقدم والذين تلقوا علاجًا سابقًا بالعلاجات المستهدفة الأخرى. تم تعيين المرضى بشكل عشوائي لتلقي Qinlock أو الدواء الوهمي مرة واحدة في اليوم في دورات مدتها 28 يومًا تتكرر حتى تطور المرض أو الآثار الجانبية غير المحتملة. أعطيت المرضى الذين تقدم مرضهم على الدواء الوهمي خيار التحول إلى Qinlock. كان البقاء على قيد الحياة بدون تقدم في المتوسط ​​6.3 أشهر للمرضى الذين تلقوا Qinlock مقارنة بشهر واحد لأولئك الذين تلقوا العلاج الوهمي.

تشمل الآثار الجانبية الأكثر شيوعًا لـ Qinlock الحاصة ، والتعب ، والغثيان ، وآلام البطن ، والإمساك ، وألم عضلي ، وإسهال ، وانخفاض الشهية ، ومتلازمة تخدير الإحمرار الراحي الأخمصي ، والقيء. يجب أن يقوم مقدمو الرعاية الصحية بالتحقق بشكل روتيني من المرضى الذين يتم علاجهم باستخدام Qinlock للتعرف على الآثار الجانبية الخطيرة المحتملة لسرطان الجلد وارتفاع ضغط الدم والخلل القلبي الذي يتجلى مع انخفاض جزء القذف.

تم منح الموافقة لشركة Deciphera Pharmaceuticals.

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Ripretinib

In this article, we will discuss Ripretinib (Dosage Overview). So, let’s get started. Indications Ripretinib is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. DosageRecommended Dosage The recommended dosage of Ripretinib is 150 mg orally once daily with or…

[pharmaphorumuk]

Blueprint pays the price of Ayvakit phase 3 miss as FDA rejects drug

  The FDA has turned down Blueprint Medicines’ Ayvakit for more general use in gas­troin­testi­nal stro­mal tu­mour – a form of stomach cancer – after approving the drug in a narrower group of GIST patients earlier this year.

The split decision for the drug has emerged because the FDA opted to review Blueprint’s marketing application for Ayvakit (avapritinib) in two parts.

The first part – which was approved in January – covered the use of the drug in GIST patients with a platelet-driven growth factor receptor alpha (PDGFRa) exon 18 mutation, including PDGFRA D842V mutations.

The second part was for fourth-line use in GIST patients, and the agency decided it wanted to see the results of an ongoing phase 3 trial comparing Ayvakit to Bayer’s Stivarga (regorafenib) before deciding on that indication.

Unfortunately for Blueprint, the results of that trial – called VOYAGER – were a bust. Ayvakit wasn’t able to show an improvement in progression-free survival (PFS) compared to Bayer’s drug when used as either a third- or fourth-line treatment for local-advanced or metastatic GIST.

The result meant the FDA’s verdict late last week was hardly a surprise, and investors seemed to have prepared themselves for disappointment as Blueprint’s share price barely moved when the news emerged.

That also reflects that analysts see the bigger potential in Ayvakit in other indications, and particularly systemic mastocytosis, a rare condition caused by an excess number of immune mast cells gathering in the body’s tissues.

Blueprint is presenting new from its phase 2 programme for Ayvakit at the ASCO meeting that start later this month, as well as new results for its RET inhibitor pralsetinib in RET-positive cancers, which analysts see as the company’s most promising pipeline drug.

The company has new data on pralsetinib on display at ASCO too, although it is playing catch-up in the market after Eli Lilly won FDA approval earlier this month for its RET inhibitor Retevmo (selpercatinib) to treat lung and thyroid cancers with a mutation or fusion in the RET gene.

Meanwhile, Blueprint is still hoping for approval of Ayvakit – its first commercial product – in the EU for PDGFRa-mutated GIST before the end of this quarter. Approximately 6% of patients with newly diagnosed GIST have PDGFRA exon 18 mutations.

Deciphera steps into fourth-line GIST void

There was good news for patients with GIST from the FDA ahead of the weekend however, after the agency approved Deciphera’s rival drug Qinlock (ripretinib) for the same fourth-line indication it had denied Ayvakit.

Deciphera’s drug provides a new treatment for patients who progress on the current kinase inhibitor  GIST therapies – Novartis’ Gleevec (imatinib). Pfizer’s Sutent (sunitinib), Stivarga and Ayvakit – said the FDA’s head of oncologic diseases Richard Pazdur.

“Today’s approval provides a new treatment option for patients who have exhausted all FDA-approved therapies for GIST,” he added.

Each year, approximately 4,000 to 6,000 adults in the US are diagnosed with GIST, according to the FDA.

The post Blueprint pays the price of Ayvakit phase 3 miss as FDA rejects drug appeared first on .

from https://pharmaphorum.com/news/blueprint-pays-the-price-of-ayvakits-phase-3-miss-as-fda-rejects-drug/