The U.S. Food and Drug Administration approved Clovis Oncology Inc.’s drug Rubraca for the treatment of adult patients with metastatic castration-resistant prostate cancer, whose tumors have a genetic mutation.
The U.S. Food and Drug Administration approved Clovis Oncology Inc.’s Rubraca (rucaparib) tablets for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.
The U.S. Food and Drug Administration approved AstraZeneca and Merck’s Lynparza (olaparib) in combination with Roche’s Avastin (bevacizumab) for the maintenance treatment of adults with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer has been tested to have either a deleterious or suspected deleterious BRCA mutation and/or genomic instability.
The U.S. Food and Drug Administration cleared expanded use of GlaxoSmithKline Plc’s Zejula as a first option to keep advanced ovarian cancer at bay in women who have responded to chemotherapy.
AstraZeneca and Merck announced that the Phase III GY004 trial of cediranib in combination with Lynparza compared to platinum-based chemotherapy in platinum-sensitive relapsed ovarian cancer failed to meet the primary endpoint.
AstraZeneca and Merck’s ovarian cancer drug Lynparza received U.S. regulatory approval for the treatment of advanced pancreatic cancer.
The U.S. Food and Drug Administration granted an expanded indication for GlaxoSmithKline’s oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor Zejula for wider use in treating ovarian cancer.
Researchers from the University of Maryland School of Medicine (UMSOM) published data from a proof-of-concept study in the journal PNAS that showed combining a PARP inhibitor with a DNMT inhibitor was effective in treating non-small cell lung cancer tumors.
AstraZeneca presented results for a late-stage clinical trial of Lynparza against prostate cancer, which the company hopes could lead to wider regulatory approval for more forms of the disease.
GlaxoSmithKline and AstraZeneca both reported late-stage clinical trial results that will likely make their competing medicines available to a wider group of ovarian cancer patients, possibly helping GSK catch the company’s rival in a highly contested drug class.