FDA advisory committee approves the use of Lynparza in pancreatic cancer
pharmafile | December 18, 2019 | News story | Research and Development | AstraZeneca, Cancer, Merck, Pancreatic cancer, lynparza
The FDA’s Oncologic Drugs Advisory Committee (ODAC) has recommended the approval of AstraZeneca and Merck’s Lynparza (olaparib) to treat pancreatic cancer.
The two companies are seeking approval of the drug to treat patients who show no improvement after receiving first line platinum-based chemotherapy.
The ODAC voted 7 to 5 on the decision for the use of the drug as a first-line maintenance monotherapy in individuals with germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma.
Lynparza’s Phase 3 trial led to significant improvements in progression free survival. According to the trial data, the drug cut the risk of disease progression or death by 47%.
Also those gBRCAm metastatic pancreatic cancer patients treated with the drug did not experience disease progression or death for 7.4 months compared to 3.8 months with placebo.
José Baselga, AstraZeneca’s Oncology R&D executive Vice President, said: “We are pleased with the ODAC’s recommendation for Lynparza and the potential to bring personalised, biomarker-targeted medicine to patients with germline BRCA-mutated metastatic pancreatic cancer.
“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. We look forward to working with the FDA as it completes the review of our application.”
Pancreatic cancer is the 12th most common cancer in men and the 11th most common in women. There were 460,000 new cases in 2018, and it has the lowest survival rate of all cancers, with just 3-6% of those diagnosed surviving for five years.
Conor Kavanagh
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