Shots: The P-III SOLO-1 study involves assessing of Lynparza (300mg, bid) as a maintenance monothx. vs PBO in 391 patients in a ratio (2:1) with newly diagnosed BRCAm advanced ovarian […]readmore
Tags : BRCA-Mutated
Shots: The EC’s approval is based on P-III POLO study assessing Lynparza (300mg, bid) as maintenance monothx. vs PBO in 154 patients in a ratio (3:2) with gBRCAm metastatic pancreatic […]readmore
Regulatory
AstraZeneca’s Lynparza (olaparib) Receives MHLW’s Orphan Drug Designation for BRCA-Mutated
Shots: The ODD is based on P-III POLO study assessing Lynparza (300mg, bid) as maintenance monothx. vs PBO in 154 patients in a ratio (3:2) with gBRCAm metastatic PC without […]readmore
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
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 SOLO-1 study result assessing Lynparza (300mg, bid) as a maintenance monothx. vs PBO in 391 patients in ratio (2:1) with BRCA-mutated advanced ovarian […]readmore
Shots: The positive opinion is based on SOLO-1 P-III study results assessing Lynparza (300mg, bid) as a monothx vs PBO in 391 patients in ratio (2:1) with BRCAm advanced ovarian […]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
Shots: The approval is based on P-III SOLO-1 trial assessing Lynparza (300 mg bid) as maintenance monothx vs PBO in 391 patients in ratio (2:1) with BRCAm advanced ovarian cancer following first-line Pt-based […]readmore
Shots: The approval is based on EMBRACA trial results assessing Talzenna (1mg) vs CT in 431 patients with BRCA-mutated HER2-negative locally advanced or metastatic breast cancer for a duration of […]readmore