AstraZeneca Announces Acceptance of Priority Review of Lynparza's (olaparib) sNDA by FDA in Patients with BRAC-Mutated Advance Ovarian Cancer
Shots:
- The filling is based on results of P-III SOLO-1 study assessing Lynparza (300mg bid) vs PBO as a monothx in 391 newly-diagnosed patients with BRCA-m advanced ovarian cancer in ratio (2:1) for up to two years
- The study showed improved results with reduction in the risk of disease progression or death by 70%- remained progression free @36 mos. (60% vs 27%). These results were presented at ESMO 2018
- Lynparza is a novel inhibitor of PARP- approved for advance and metastatic breast cancer in Japan. Lynparza has received a PDUFA date in Q1’19 for BRAC-m advance ovarian cancer & is jointly developed by AstraZeneca & MSD
Ref: AstraZeneca | Image: AstraZeneca
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