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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).

References

  1. Updated public participation information: December 17, 2019: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement. FDA. Published December 4, 2019. https://bit.ly/2DOaWuX. 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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