FDA approves maintenance olaparib for BRCA-mutated metastatic pancreatic cancer
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The FDA approved olaparib as maintenance treatment for adults with deleterious or suspected deleterious germline BRCA-mutated metastatic pancreatic cancer, according to a press release from the drug’s manufacturer.
The approval of olaparib (Lynparza; AstraZeneca, Merck) applies to patients whose disease did not progress after at least 16 weeks of first-line platinum chemotherapy.
“Patients with advanced pancreatic cancer historically have faced poor outcomes due to the aggressive nature of the disease and limited treatment advances over the last few decades,” Dave Fredrickson, executive vice president and head of the oncology business unit at AstraZeneca, said in the release. “[Olaparib] is now the only approved targeted medicine for biomarker-selected patients with advanced pancreatic cancer.”
Additionally, the FDA approved BRACAnalysis CDx (Myriad Genetics) as a companion diagnostic test to help clinicians identify patients with BRCA-mutated metastatic pancreatic cancer who are candidates for olaparib, according to a press release from Myriad.
BRACAnalysis CDx, an in vitro device, detects and classifies variants in the protein coding regions and intron/exon boundaries of BRCA1 and BRCA2 genes. This is done using genomic DNA gathered from blood.
Earlier this month, the FDA’s Oncologic Drugs Advisory Committee voted 7-5 to support approval of olaparib, a first-in-class poly(ADP-ribose) polymerase (PARP) inhibitor, for patients with this subset of pancreatic cancer.
The FDA based its approval on results of the randomized phase 3 POLO trial, which showed patients receiving olaparib had longer PFS than those receiving placebo (7.4 months vs. 3.8 months; HR = 0.53; 95% CI, 0.35-0.82).
“[Patients with] metastatic pancreatic cancer have been waiting a long time for new therapy options for their devastating disease,” Julie Fleshman, president and CEO of Pancreatic Cancer Action Network, said in the Merck press release. “Today’s approval of [olaparib] provides an exciting new treatment option for patients with germline BRCA-mutated metastatic pancreatic cancer.”
Reference:
Golan T, et al. N Engl J Med. 2019;doi:10.1056/NEJMoa1903387.