Ripretinib Approved: Advanced Gastrointestinal Stromal Tumor

The FDA has approved ripretinib (QinlockTM, Deciphera Pharmaceuticals, LLC) for adults with metastatic gastrointestinal stromal tumor (GIST) previously treated with at least three kinase inhibitors, including imatinib. Gastrointestinal stromal tumor is a rare tumor type with a yearly incidence of around 4,000 to 6,000 in the United States. "Despite the progress that has been made over the past 20 years in developing treatments for GIST, including four FDA-approved targeted therapies––imatinib in...
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Kaposi Sarcoma: Pomalidomide Granted Accelerated Approval

In the first new drug approval for Kaposi sarcoma in over 20 years, the FDA has expanded the indication for pomalidomide (Pomalyst®, Celgene) in an accelerated approval, both for HIV-negative patients with Kaposi sarcoma and for patients with AIDS-related Kaposi sarcoma resistant to highly active antiretroviral therapy (HAART). The approval was based on data from Study 12-C-0047 (NCT01495598), an open-label, single-arm phase 1/2 trial in which 28 patients with Kaposi sarcoma, including 18 who we...
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Enhancing Treatment for Patients With GIST: Michael Heinrich, MD

Because gastrointestinal stromal tumor (GIST) has an estimated incidence of 3,300 to 6,000 new cases per year in the United States, comprising less than 1% of all gastrointestinal tumors, the rarity of this tumor type can make it more challenging for oncologists and other members of the cancer care team to stay up to date on the latest treatments. Michael C. Heinrich, MD, lead investigator of the phase 1 NAVIGATOR trial, recently spoke with i3 Health about the FDA's approval of avapritinib (Ayva...
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Avapritinib for PDGFRA Exon 18-Mutated GIST: Michael Heinrich, MD

Up to 10% of patients with gastrointestinal stromal tumor (GIST) harbor platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutations, which have been linked to resistance to standard GIST therapies. The FDA's recent approval of avapritinib (AyvakitTM, Blueprint Medicines) for adults with unresectable or metastatic GIST with PDGFRA exon 18 mutations has given these patients a highly promising treatment option. In this interview, Michael C. Heinrich, MD, lead investigator of the phase ...
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Tazemetostat Approved for Epithelioid Sarcoma

The FDA has granted accelerated approval to tazemetostat (TazverikTM, Epizyme) for the treatment of adult and pediatric patients aged 16 or older with unresectable locally advanced or metastatic epithelioid sarcoma. Epithelioid sarcoma, which often occurs in young adults and comprises less than 1% of all soft tissue sarcomas, carries a high risk of local and regional spread, and it metastasizes in approximately 30% to 50% of cases. Tazemetostat, a first-in-class selective enhancer of zeste ...
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