Cancer Space Update: Label Expansions, Data Readouts In Focus
Zacks Investment Research | Jan 18, 2018 10:23PM ET
After a couple of quiet weeks, the cancer space witnessed some activity with FDA actions on label expansion and positive data readouts on major drugs from several companies. Meanwhile, a biosimilar for a blockbuster cancer drug received approval in Europe. A new drug was also granted approval for the treatment of leukemia.
Amgen, Inc.’s (NASDAQ:AMGN) multiple myeloma drug, Kyprolis, received FDA nod to include overall survival (“OS”) data from the head-to-head ENDEAVOR study on its label. The first CAR-T therapy to receive approval, Novartis AG’s (NYSE:NVS) Kymriah, got a boost as the FDA accepted a supplemental Biologics License Application (sBLA) seeking label expansion in diffuse large B-cell lymphoma (“DLBCL”). Moreover, AstraZeneca’s (NYSE:AZN) Lynparza got the FDA nod for label expansion in metastatic breast cancer. Teva Pharmaceutical (NYSE:TEVA) also announced Amgen Gets FDA Nod to Add ENDEAVOR Data on Kyprolis Label )
Amgen Inc. Price
Novartis sBLA for CAR-T Therapy Kymriah Accepted by FDA )
Novartis AG Price
AstraZeneca's Lynparza Label Now Includes Breast Cancer )
Astrazeneca (LON:AZN) PLC Price
Merck Strong on Confirmatory Phase III Lung Cancer Study )
Merck & Company, Inc. Price
Exelixis, Ipsen Report Positive Results on Lead Cancer Drug )
Exelixis, Inc. Price
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