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Novarits: breakthrough therapy designation to capmatinib for NSCLC, EC approval for Lucentis in preterm infants with ROP

The U.S. Food and Drug Administration granted Breakthrough Therapy Designation to capmatinib (INC280) as a first-line treatment for patients with metastatic MET exon14 skipping-mutated non-small cell lung cancer (NSCLC), said John Tsai, MD, Head of Global Drug Development and Chief Medical Officer, Novartis.

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FDA Approves Genentech’s Tecentriq in Combination With Chemotherapy for the Initial Treatment of Adults With Extensive-Stage Small Cell Lung Cancer

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),today announced that the U.S. Food and Drug Administration (FDA)approved Tecentriq® (atezolizumab), in combinationwith carboplatin and etoposide (chemotherapy), for the initial(first-line) treatment of adults with extensive-stage small cell lungcancer (ES-SCLC).

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Merck and Pfizer Announce Investigational Immunotherapy Avelumab Receives FDA Fast Track Designation for Metastatic Merkel Cell Carcinoma

Merck KGaA and Pfizer have announced that the US Food and Drug Administration (FDA) has granted avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, Fast Track designation for the treatment of metastatic Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer.

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