Tags : BRCA-Mutated

Clinical Trials

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

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 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

Regulatory

AstraZeneca and MSD’s Lynparza (olaparib) Receive European Commission’s Approval as

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 cancer following 1L platinum-based CT The P-III SOLO results demonstrated that 60% of patients showed disease-free progression after three yrs. of treatment and only 27% […]Read More

Regulatory

AstraZeneca and Merck’s Lynparza (olaparib) Receive EU’s Approval as a

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 triple negative) breast cancer  The P-III study results: 42% reduction in the risk of disease progression or death; PFS (7.0mos. vs 4.2mos.); ORR (52% vs […]Read More

Regulatory

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