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Latest News

FDA approves ripretinib for advanced gastrointestinal stromal tumor

On May 15, 2020, the Food and Drug Administration approved ripretinib (QINLOCK™, Deciphera Pharmaceuticals, LLC.), for adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. Efficacy was evaluated in INVICTUS (NCT03353753), an international, multi-center, randomized (2:1), double-blind, placebo-controlled trial in 129 patients with...

FDA grants accelerated approval to rucaparib for BRCA-mutated metastatic castration-resistant prostate cancer

On May 15, 2020, the Food and Drug Administration granted accelerated approval to rucaparib (RUBRACA®, Clovis Oncology, Inc.) for patients with deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Efficacy was investigated in TRITON2 (NCT02952534), an ongoing, multi-center, single arm clinical trial...

FDA approves nivolumab plus ipilimumab for first-line mNSCLC (PD-L1 tumor expression ≥1%)

On May 15, 2020, the Food and Drug Administration approved the combination of nivolumab (OPDIVO®, Bristol-Myers Squibb Co.) plus ipilimumab (YERVOY®, Bristol-Myers Squibb Co.) as first-line treatment for patients with metastatic non-small cell lung cancer whose tumors express PD-L1(≥1%), as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma...

FDA grants accelerated approval to pomalidomide for Kaposi sarcoma

From the American Society of Clinical Oncology in cooperation with the Food and Drug Administration (FDA) and as a service to our members, ASCO will periodically distribute information about newly approved therapies for cancer patients. This helps FDA inform oncologists and professionals in oncology-related fields about recent approvals in a timely manner. Included in the...

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