By: Nichole Tucker astaastFrom: targetedonc.com Positive findings from the phase 3 EMERALD study led to a new drug application for elacestrant as treatment of estrogen receptor-positive, HER2-negative advanced or metastatic breast cancer. The FDA has granted the application priority review. The FDA has accepted a new drug application for the selective estrogen receptor degrader, elacestrant, and granted it priority review …
Gilead to get speedy FDA review for second CAR-T cell therapy in lymphoma
By: Alaric DeArment From: medcitynews.com The biotech company’s Kite Pharma subsidiary said the FDA had granted priority review for KTE-X19 in mantle cell lymphoma. The company already markets the CAR-T Yescarta for diffuse large B-cell lymphoma. A subsidiary of Gilead Sciences could have its second CAR-T cell therapy on the market by this summer if the Food and Drug Administration …
FDA Grants Priority Review to Olaparib Plus Bevacizumab as Frontline Maintenance in Ovarian Cancer
By: Gina Columbus From: onclive.com The FDA has granted a priority review designation to a supplemental new drug application (sNDA) for the combination of olaparib (Lynparza) and bevacizumab (Avastin) for the maintenance treatment of patients with advanced ovarian cancer who are in complete or partial response (PR) to first-line platinum-based chemotherapy with bevacizumab.1 The designation is based on results from …
Pfizer Gains Priority Review For Breast Cancer Drug, Can It Succeed?
By: Terry Chrisomalis From: seekingalpha.com Summary Pfizer obtains priority review for talazoparib in treating patients with germline BRCA-mutated breast cancer, with FDA decision date by December 2018. Treatment with talazoparib in BRCA-mutated breast cancer reduced the risk of disease progression by 46%. If talazoparib is approved by the FDA it will have to go up against other competing drugs for the same …