Britain’s AstraZeneca clinched expanded regulatory backing for two medications, including one for the blockbuster cancer treatment Lynparza, in a development pipeline that now includes a possible coronavirus vaccine.
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 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.
Despite the COVID-19 pandemic, the U.S. Food and Drug Administration has managed to stay fairly on track in terms of evaluating new drug and supplemental new drug applications. Here is a look at what is on the schedule for the next two weeks.
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.
Oncology is one of the most exciting areas in healthcare, as novel therapies continue to emerge that move forward our molecular understanding of the disease and offer effective treatment advances. This Q&A explores oncology innovation with Kantar’s Stephanie Hawthorne, Vice President of Oncology and Specialty Therapeutics.
AstraZeneca and Merck’s ovarian cancer drug Lynparza received U.S. regulatory approval for the treatment of advanced pancreatic cancer.
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.
The European Commission approved Pfizer Inc.’s Talzenna (talazoparib), an oral polypolymerase inhibitor, as monotherapy for the treatment of adult patients with germline breast cancer susceptibility gene 1/2-mutations who have human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer.
Lynparza was approved as a first-line maintenance treatment for a type of advanced ovarian cancer by the European Commission.