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 celllungcancer (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 celllung carcinoma in patients whose tumors have certain EGFR gene mutations detected by the FDA-approved diagnostic test.
Peregrine Pharmaceuticals announced interim results from its randomized, double-blind, placebo-controlled Phase 2b trial of bavituximab in patients with refractory non-small celllungcancer (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 celllungcancer (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 celllungcancer (NSCLC).
KAEL-GemVax announced results from its Phase 2 study of vaccination with the telomerase peptide GV1001 after chemoradiotherapy in Stage III non-small celllungcancer (NSCLC) patients.