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

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

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

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: Twitter

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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