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(Sharecast News) - AstraZeneca announced on Monday, alongside its partner MSD, that 'Lynparza', or olaparib, has been approved in the United States for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma, or pancreatic cancer, whose disease had not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen.
The FTSE 100 pharmaceutical giant said patients would be selected for therapy based on an FDA-approved companion diagnostic for Lynparza.
It said the approval followed the recommendation from the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) on 17 December for Lynparza in the indication, and was based on results from the pivotal phase 3 POLO trial, which was published in the New England Journal of Medicine and presented at the 2019 American Society of Clinical Oncology Annual Meeting.
Results showed a statistically significant and clinically meaningful improvement in progression-free survival, where Lynparza nearly doubled the time patients with gBRCAm metastatic pancreatic cancer lived without disease progression or death to a median of 7.4 months, compared to 3.8 months on placebo.
The safety and tolerability profile of Lynparza in the POLO trial was in line with that observed in prior clinical trials.
"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," said AstraZeneca's executive vice-president of the oncology business unit, Dave Fredrickson.
"Lynparza is now the only approved targeted medicine in biomarker-selected patients with advanced pancreatic cancer."
Roy Baynes, senior vice-president and head of global clinical development, and chief medical officer at MSD Research Laboratories, added that Lynparza "embodies" MSD's and AstraZeneca's commitment to advance the treatment of challenging types of cancer, including metastatic pancreatic cancer.
"The expanded approval of Lynparza represents a significant milestone for patients and supports the value of germline BRCA testing in patients with this disease."
Hedy Kindler, co-principal iInvestigator of the POLO trial and professor of medicine at the University of Chicago Medicine said the approval of olaparib based on the POLO results gave clinicians an "important first-line maintenance treatment option".
"[The treatment] nearly doubled the progression-free survival benefit in patients with germline BRCA-mutated metastatic pancreatic cancer."
At 0813 GMT, shares in AstraZeneca were down 0.66% at 7,694p.
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