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FDA Grants Olaparib Orphan Drug Designation for Pancreatic Cancer

Gina Columbus @ginacolumbusonc
Published: Tuesday, Oct 16, 2018

Dr. Roy Baynes

Roy Baynes, MD, PhD
The FDA has granted olaparib (Lynparza) an orphan drug designation for the treatment of patients with pancreatic cancer, according to AstraZeneca and Merck, the developers of the PARP inhibitor.1


  1. AstraZeneca. US FDA grants Lynparza orphan drug designation for pancreatic cancer. Published October 16, 2018. Accessed October 16, 2018.
  2. Pujade-Lauraine E, Ledermann JA, Selle F, et al. Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a double-blind, randomised, placebo-controlled, phase 3 trial [published online July 25]. Lancet Oncol. doi: 10.1016/S1470-2045(17)30469-2.
  3. Gourley C, Friedlander M, Matalonis U, et al. Clinically significant long-term maintenance treatment with olaparib in patients (pts) with platinum-sensitive relapsed serous ovarian cancer (PSR SOC). J Clin Oncol. 2017;35(suppl; abstr 5533).

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