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A look back at all the FDA news in oncology from the month of January 2019, including several new approvals, breakthrough therapy designations, and a partial clinical hold.

Bristol-Myers Squibb has announced its decision to withdraw a supplemental biologics license application currently with the FDA seeking frontline approval for the combination of nivolumab and ipilimumab for patients with advanced non–small cell lung cancer with tumor mutational burden ≥10 mutations per megabase.

A supplemental biologics license application submitted to the FDA for atezolizumab, carboplatin, and nab-paclitaxel has been accepted. The application, based on findings from the phase III IMpower130 trial, is seeking the agent's approval for patients with metastatic nonsquamous non–small cell lung cancer.

Increasing clinical relevance of less common gene signatures and alterations is leading to a benefit from broad-panel next-generation sequencing testing for patients with metastatic non–small cell lung cancer, according to an expert at Memorial Sloan Kettering Cancer Center.