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Dec. 16 Quick Takes: MacroGenics' margetuximab approved for breast cancer; plus sotorasib, Mesoblast, Cardior, Takeda, Allero     

December 17, 2020 2:40 AM UTC

First approval for MacroGenics
FDA approved Margenza margetuximab-cmkb from MacroGenics Inc. (NASDAQ:MGNX) the company’s first approved drug  to treat metastatic HER2-positive breast cancer patients who have received two or more anti-HER2 regimens, at least one of which was for metastatic disease. The company said it is the first HER2-targeted therapy to have improved progression-free survival (PFS) versus Herceptin trastuzumab, both combined with chemotherapy, in a head-to-head Phase III trial.

First KRAS G12C reaches FDA’s desk
Amgen Inc. (NASDAQ:AMGN) said it submitted an NDA for its closely watched KRAS inhibitor sotorasib to treat locally advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutation. The compound, which has breakthrough therapy designation from FDA, will be assessed under the agency’s real-time cancer review pilot...