AstraZeneca’s Lynparza (olaparib) Receives MHLW’s Orphan Drug Designation for BRCA-Mutated Metastatic Pancreatic Cancer

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 disease progression on 1L Pt. based CT
• The P-III POLO study results: improvement in PFS (7.4 vs 3.8mos.); 47% reduction in disease progression; patients with measurable disease at baseline, responded patients (23% vs 12%); median duration of treatment in excess of 2yrs. (24.9 vs 3.7mos.); median OS (18.9 vs 18.1mos.)
• Lynparza is a first-in-class PARP inhibitor acts by targeting DDR in cells/tumors harboring a deficiency in HRR (BRCA1& 2 mutation) and has received the US FDA’s approval in Dec’2019 with its ongoing regulatory reviews in the EU and other regulatory bodies

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