Regulatory Roundup: FDA reviewing GSK, Takeda applications for earlier lines of cancer treatment; plus Novartis, Halozyme-Genentech, MacroGenics, CSL, Lilly

FDA is reviewing four earlier or additional indications for a slate of cancer drugs, plus a first-time application for MacroGenics’ anti-HER2 mAb. The agency also approved the first quadrivalent flu vaccine and a CV application for a diabetes therapy.

Via the Real-Time Oncology Review pilot program, FDA is reviewing an sNDA for Zejula niraparib from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) as first-line maintenance treatment of advanced ovarian cancer in women who responded to platinum-based chemotherapy. The PARP inhibitor is approved in the U.S. and China as maintenance treatment for women with recurrent ovarian cancer (see “Zai Ready for Mainland China Launch”). ...