Tags : Lynparza

AstraZeneca and MSD’s Lynparza (olaparib) Receive EU’s Approval as 1L

Shots: The approval is based on a biomarker subgroup analysis of P-III PAOLA-1 study assessing Lynparza + bevacizumab vs bevacizumab alone as 1L maintenance treatment in patients with newly diagnosed advanced FIGO Stage III-IV high-grade serous/ endometrioid ovarian, fallopian tube, peritoneal cancer who had CR/PR to 1L treatment with Pt. based CT and bevacizumab Results: reduction […]Read More

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 MSD Report Results of Lynparza in P-III PROfound

Shots: The P-III PROfound study involves assessing of Lynparza vs enzalutamide or abiraterone in patients with mCRPC, progressed on prior treatment with NHA treatments (abiraterone or enzalutamide) along with tumor mutation in BRCA1/2, ATM or one of 12 other genes involved in the HRR pathway The P-III PROfound study demonstrated improvement in OS and is […]Read More

AstraZeneca and MSD Report Results of Cediranib + Lynparza in

Shots: The P-III GY004 study involves assessing of cediranib + Lynparza vs Lynparza as monothx. vs standard platinum-based CT in patients with recurrent platinum-sensitive OC, fallopian tube, or primary peritoneal cancer patients, with/without a BRCA mutation The P-III GY004 study resulted in not meeting its 1EPs in IIT population i.e. an improvement in PFS when […]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