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 […]readmore
Tags : olaparib
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 US FDA has accepted the sNDA for Lynparza and granted PR status based on P-III PROfound study assessing Lynparza vs hormonal agents (abiraterone or enzalutamide) in patients with […]readmore
Shots: The US FDA has accepted the sNDA and granted the PR for Lynparza in combination with bevacizumab as a maintenance therapy for patients with advanced ovarian cancer who are […]readmore
Shots: The US FDA’s ODAC voted 7 to 5 in favor of recommending Lynparza as 1L maintenance monotherapy for patients with gBRCAm metastatic adenocarcinoma of the pancreas that has not […]readmore
Shots: The approval is based on P-III SOLO-1 study assessing Lynparza (bid, 300mg) as maintenance therapy vs PBO in 391 patients in a ratio (1:1) with a deleterious or suspected […]readmore
Shots: Myriad to seek approval based on the P-III PROfound results assessing Lynparza vs enzalutamide or abiraterone acetate in patients with metastatic castration-resistant prostate cancer who have failed prior treatment […]readmore
Shots: The US FDA approved FoundationOne CDx as a CDx for Lynparza (co-developed & co-commercialized by Merck & AstraZeneca) for 1L maintenance therapy in BRCA-mutated advanced ovarian cancer The test […]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