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 HRR- mutated mCRPC who have progressed on prior therapies with new hormonal therapies including patients with BRCA1/2- ATM and CDK12 mutations
• The P-III PROfound study results: 66% reduction in risk of disease progression or death; rPFS in patients with BRCA1/2- or ATM-mutated mCRPC (7.4 vs 3.6mos.); rPFS in the overall HRRm population (5.8 vs 3.5mos.)
•  Lynparza (olaparib) is a first-in-class PARP inhibitor acts by targeting DNA damage response (DDR) in cells/tumors harboring a deficiency in HRR (BRCA1& 2 mutation) with its expected PDUFA date in Q2’20

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