FDA approves olaparib for gBRCAm metastatic pancreatic adenocarcinoma | FDA

FDA approves olaparib for gBRCAm metastatic pancreatic adenocarcinoma | FDA



FDA approves maintenance treatment for adult patients with harmful or suspected harmful gBRCAm metastatic pancreatic adenocarcinoma

The Food and Drug Administration approved olaparib (LYNPARZA®, AstraZeneca Pharmaceuticals LP) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma, as detected by an FDA-approved test, whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. The FDA also approved the BRACAnalysis CDx test (Myriad Genetic Laboratories, Inc.) as a companion diagnostic for the selection of patients with pancreatic cancer for treatment with olaparib based upon the identification of deleterious or suspected deleterious germline mutations in BRCA1 or BRCA2 genes. In general, the adverse reaction profile of olaparib observed in POLO is consistent with the known safety profile of olaparib. The most common adverse reactions to olaparib (≥10%) in clinical trials include nausea, fatigue, vomiting, abdominal pain, anemia, diarrhea, dizziness, neutropenia, leukopenia, nasopharyngitis/upper respiratory tract infection/influenza, respiratory tract infection, arthralgia/myalgia, dysgeusia, headache, dyspepsia, decreased appetite, constipation, stomatitis, dyspnea, and thrombocytopenia.

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