Nivolumab/Ipilimumab Approved for Metastatic Non-Small Cell Lung Cancer

For patients with advanced non-small cell lung cancer (NSCLC) that test positive for programmed death-ligand 1 (PD-L1), the FDA just approved an effective treatment: nivolumab (Opdivo ®, Bristol Myers Squibb) plus ipilimumab (Yervoy®, Bristol Myers Squibb). A companion diagnostic, PD-L1 IHC 28.8 pharmDx (Agilent Technologies, Inc.), was also FDA approved for selecting patients with NSCLC for treatment with nivolumab/ipilimumab. Previously approved to treat advanced kidney cancer, advanced liver ...
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Rucaparib Approved: BRCA-Mutated Metastatic CRPC

The FDA has granted accelerated approval to rucaparib (Rubraca®, Clovis Oncology, Inc.) for patients with deleterious germline and/or somatic BRCA-mutated metastatic castration-resistant prostate cancer (CRPC) who have previously received one line of taxane-based chemotherapy and one or more lines of androgen receptor-directed therapy. The approval was based on TRITON2 (NCT02952534), a phase 2 clinical trial which enrolled 115 patients with BRCA-mutated metastatic CRPC. Patients received 600 mg ...
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Pemigatinib for Cholangiocarcinoma: An Interview With Ghassan Abou-Alfa, MD, MBA

Fibroblast growth factor receptor (FGFR) 2 gene alterations can occur in the pathogenesis of cholangiocarcinoma. Pemigatinib (PemazyreTM, Incyte Corporation), a newly FDA approved oral inhibitor of FGFR2, has shown efficacy in patients with previously treated, locally advanced, or metastatic cholangiocarcinoma with and without FGFR2 gene alterations. Approval was granted based a study led by Ghassan Abou-Alfa, MD, MBA from Memorial Sloan Kettering Cancer Center. In an interview with i3 Health, D...
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Pemigatinib Approved for Cholangiocarcinoma

Often, fibroblast growth factor receptor (FGFR) 2 gene alterations occur in the pathogenesis of cholangiocarcinoma. The FDA recently approved an oral inhibitor of FGFR2, pemigatinib (PemazyreTM, Incyte Corporation), which has shown efficacy in patients with previously treated, locally advanced, or metastatic cholangiocarcinoma with and without FGFR2 gene alterations. FoundationOne®CDx was also approved as a companion diagnostic test for this indication.  FDA approval was based on a cli...
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Nivolumab Shows Long-Term Efficacy in Advanced RCC

In patients with previously treated advanced renal cell carcinoma (RCC), nivolumab significantly increases overall survival and response rates compared with everolimus, according to the final updated analysis of the phase 3 CheckMate 025 trial. A randomized, open-label trial, CheckMate 025 enrolled 821 patients with advanced RCC previously treated with antiangiogenic therapies. Patients were randomized in a 1:1 ratio to receive 3 mg/kg of nivolumab intravenously every two weeks or 10 mg of evero...
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