Shots:

• The approval follows the US FDA Oncologic drugs Advisory Committee (ODAC) on 17 Dec based on P-III POLO trial- which involves assessing of Lynparza tablets (300 mg bid) as maintenance monothx vs. PBO in 154 patients in ratio (3:2) with gBRCAm metastatic pancreatic cancer whose disease had not progressed on at least 16 weeks on 1L Pt-based chemotherapy
• The study resulted in improvement in median progression-free survival (7.4 mos. vs 3.8 mos.)- 47% reduced risk of disease progression or death- respond ratio (23% vs 12%)- median duration of treatment in excess of 2 yrs. (24.9 mos. vs 3.7 mos.)- OS (18.9 mos. vs 18.1 mos.)- safe and tolerable
• AstraZeneca and Merck & Co’s (MSD outside the United States and Canada) Lynparza (olaparib) is a first-in-class PARP inhibitor targeted to block DNA damage response (DDR) in cells/tumors harboring a deficiency in homologous recombination repair (HRR) and is approved in 65 countries

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Ref: AstraZeneca | Image: AstraZeneca