AstraZeneca and MSD’s Lynparza (olaparib) Receive NMPA’s Approval as 1L Maintenance Therapy for BRCA-Mutated Advanced Ovarian Cancer

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 deleterious germline or somatic BRCA/BRCA2 mutated ovarian cancer following 1L platinum-based CT
• The P-III SOLO-1 study result: reduction in disease progression or death by 70%; progression-free women @3yrs. (60% vs 27%); mPFS (not reached vs 13.8 mos.); median duration of follow up (40.7 vs 41.2 mos.); safety profile is consistent with the previous studies with no detriment to QoL
• Lynparza is a PARP inhibitor act by blocking DNA damage response in tumors harboring HRR mutation including BRCA1/BRCA2, jointly developed and commercialized by AstraZeneca and MSD and is an approved therapy for the treatment of advanced ovarian cancer and metastatic breast cancer

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