The Food and Drug Administration has granted accelerated approval to Tabrecta™ (capmatinib; Novartis).
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The approval of Imfinzi is based on the positive PFS data from the Phase 3 PACIFIC trial.
Genentech announced that the Food and Drug Administration (FDA) has approved Tecentriq (atezolizumab) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK gene abnormalities.
The FDA has accepted and granted Priority Review for a supplemental New Drug Application (sNDA) for Xalkori (crizotinib; Pfizer).
The US Food and Drug Administration (FDA) has approved Tagrisso (osimertinib; AstraZeneca) for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.
The FDA has approved Gilotrif (afatinib) with the therascreen EGFR RQG PCR kit for the treatment of metastatic non-small cell lung carcinoma in patients whose tumors have certain EGFR gene mutations detected by the FDA-approved diagnostic test.
Sorafenib does not improve OS for patients with advanced NSCLC, but it may benefit a subset of patients whose tumors harbor EGFR mutations.
Peregrine Pharmaceuticals announced interim results from its randomized, double-blind, placebo-controlled Phase 2b trial of bavituximab in patients with refractory non-small cell lung cancer (NSCLC).
Eli Lilly and Company announced today that the Phase 3 POINTBREAK trial did not meet its primary endpoint of improved overall survival for patients with nonsquamous non-small cell lung cancer (NSCLC) who were randomized to receive a combination of Alimta (pemetrexed for injection) with bevacizumab (Avastin; Genentech) and carboplatin induction followed by Alimta plus bevacizumab maintenance-the Alimta arm-compared to the combination of paclitaxel (Taxol; Bristol-Myers Squibb) with bevacizumab and carboplatin followed by bevacizumab maintenance-the paclitaxel arm.
Boehringer Ingelheim announced results from its LUX-Lung 3 Phase 3 clinical trial of afatinib in patients with advanced non-small cell lung cancer (NSCLC).