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FDA Panel to Review Olaparib Application in Metastatic Pancreatic Cancer

Gina Columbus @ginacolumbusonc
Published: Thursday, Dec 05, 2019

The FDA has scheduled an Oncologic Drugs Advisory Committee hearing for December 17, 2019, to discuss a supplemental new drug application for olaparib (Lynparza) tablets as a maintenance treatment of adult patients with deleterious or suspected deleterious BRCA-mutant metastatic pancreatic adenocarcinoma whose disease has not progressed on frontline platinum-based chemotherapy.1

= .25).


  1. Updated public participation information: December 17, 2019: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement. FDA. Published December 4, 2019. Accessed December 5, 2019.
  2. Kindler HL, Hammel P, Reni M, et al. Olaparib as maintenance treatment following first-line platinum-based chemotherapy (PBC) in patients (pts) with a germline BRCA mutation and metastatic pancreatic cancer (mPC): Phase III POLO trial. Presented at: 2019 ASCO Annual Meeting; Chicago, IL; May 31-June 4, 2019. Abstract LBA4.
  3. Golan T, Hammel P, Reni M, et al. Maintenance Olaparib for Germline BRCA-Mutated Metastatic Pancreatic Cancer. N Engl J Med. doi: 10.1056/NEJMoa1903387
  4. Hammel P, Kindler HL, Reni M, et al. Health-related quality of life in patients with a germline BRCA mutation and metastatic pancreatic cancer receiving maintenance olaparib. Ann Oncol. 2019;30(suppl_5): mdz406. doi: 10.1093/annonc/mdz406.

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