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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.