Tags : BRCA-Mutated

AstraZeneca and MSD Report Five Year Data of Lynparza in

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 cancer following 1L Pt.-based CT for ~2yrs. or until disease progression Five-year follow-up data demonstrated a 67% reduction in risk of disease progression or death, […]Read More

AstraZeneca and Merck & Co’s Lynparza Receive the US FDA’s

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 maintenance monothx vs. PBO in 154 patients in ratio (3:2) with gBRCAm metastatic pancreatic cancer whose disease had not progressed on at least 16 weeks […]Read More

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 m-triple-negative or HR+/HER2- breast cancer, prior treated with 3L CT regimen The P-III EMBRACA study results: mPFS (8.6 mos.vs 5.6mos.); ORR (62.6% vs 27.2%); 46% […]Read More

AstraZeneca and Merck’s Lynparza (olaparib) Receives FDA’s Approval for 1L

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 CT for two years P-III SOLO-1 trial results: reduction in risk of death 70%, patients remained progression free for three years, with safe and well-tolerated Lynparza (olaparib) is […]Read More