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news.AstraZeneca and Merck have secured approval from the US Food and Drug Administration (FDA) for Lynparza (olaparib) as a first-line maintenance treatment for germline BRCA-mutated metastatic pancreatic cancer.
Image: AstraZeneca and Merck have secured FDA approval for pancreatic cancer drug Lynparza. Photo: courtesy of AstraZeneca.
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The US regulator has approved Lynparza as a maintenance treatment for adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma (pancreatic cancer) whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen.
Lynparza, a first-in-class PARP inhibitor, is claimed to be the first targeted treatment to block DNA damage response (DDR) in cells/tumours harbouring a deficiency in homologous recombination repair (HRR) such as mutations in BRCA1 and/or BRCA2.
The therapy will be provided to the patients based on an FDA-approved companion diagnostic for Lynparza.
Myriad Genetics’ BRACAnalysis CDx genetic test will be used to provide the therapy for eligible metastatic pancreatic cancer patients in the US. The genetic test will help detect the presence of a BRCA1 or BRCA2 gene mutation.
AstraZeneca oncology business unit executive vice president Dave Fredrickson said: “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.”
The approval was based on data from the pivotal phase III POLO trial, which demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS).
POLO is a randomised, double-blinded, placebo-controlled and multi-centre trial of Lynparza tablets (300mg twice daily) as maintenance monotherapy against placebo.
The study randomised 154 patients with gBRCAm metastatic pancreatic cancer whose disease had not progressed on first-line platinum-based chemotherapy.
The PFS is the primary endpoint of the trial, while overall survival, time to second disease progression, overall response rate and health-related quality of life are the secondary endpoints.
MSD Research Laboratories chief medical officer, global clinical development head and senior vice president Roy Baynes said: “Lynparza embodies MSD’s and AstraZeneca’s commitment to advance the treatment of challenging types of cancer, including metastatic pancreatic cancer.”
In November this year, AstraZeneca secured priority review from the US FDA or its cancer drug Imfinzi (durvalumab) for the treatment of extensive-stage small cell lung cancer (SCLC) in previously untreated patients.
