Shots: The approval follows the US FDA Oncologic drugs Advisory Committee (ODAC) on 17 Dec based on P-III POLO trial, which involves assessing of Lynparza tablets (300 mg bid) as […]readmore
Tags : Germline
Regulatory
Pfizer’s Talzenna (talazoparib) Receives European Commission Approval for Germline BRCA-Mutated
Shots: The approval is based on P-III EMBRACA study results assessing Talzenna (qd, 1mg) vs CT (capecitabine/eribulin/gemcitabine/vinorelbine) in 431 patients in ratio (2:1) with inherited BRCA1/2 mutation & LA or […]readmore
Shots: The approval is based on P-III OlympiAD trial assessing Lynparza (300mg, bid) vs CT (capecitabine, eribulin or vinorelbine) in 302 patients with germline BRCA1- and/or BRCA2-mutated, HER2-negative (HR-positive or […]readmore