An advisory committee of the US Food and Drug Administration (FDA) has recommend Lynparza (olaparib) as treatment for germline BRCA-mutated (gBRCAm) metastatic adenocarcinoma of the pancreas.
Jointly developed by AstraZeneca and MSD, Lynparza has been recommended by the FDA’s Oncologic Drugs Advisory Committee (ODAC) as a first-line maintenance monotherapy for pancreatic cancer in patients, whose disease has not progressed after first-line platinum-based chemotherapy.
AstraZeneca oncology R&D executive vice president José Baselga said: “We are pleased with the ODAC’s recommendation for Lynparza and the potential to bring a 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.”
The sNDA submission for Lynparza is based on Phase III POLO clinical trial
Lynparza is a PARP inhibitor that blocks DNA damage response (DDR) in tumour cells with a deficiency in homologous recombination repair (HRR), including mutations in BRCA1 and BRCA2, and leads to the cancer cell death.
The FDA has accepted the supplemental New Drug Application (sNDA) for Lynparza in August 2019, with priority review and fixed a prescription drug user fee act (PDUFA) date for the fourth quarter of 2019.
AstraZeneca said that the sNDA submission was supported by the results from Phase III POLO clinical trial, whose results demonstrated statistically significant and clinically meaningful improvement in progression-free survival and reduced the risk of disease progression or death, compared to placebo.
The ODAC provides expert advice and recommendations to the FDA, on marketed and potential new medicines for use in the treatment of cancer. The FDA would consider the recommendation in its review of the submission.
Lynparza has been approved in the US, EU, Japan and several other countries as a treatment for BRCA-mutated advanced ovarian cancer, and has also been approved in 44 countries for germline BRCA-mutated, HER2-negative, metastatic breast cancer.
MSD Research Laboratories senior vice president and global clinical development head, chief medical officer Roy Baynes said: “We are encouraged by the ODAC’s favourable vote for Lynparza as a 1st-line maintenance therapy in germline BRCA-mutated metastatic pancreatic cancer. This recommendation is a significant step towards reaching our goal to help patients with this deadly disease.”
