Lynparza recommended for approval in EU by CHMP for BRCA-mutated metastatic pancreatic cancer

AstraZeneca and MSD Inc., Kenilworth, N.J., US announced that Lynparza (olaparib) has been recommended for marketing authorisation in the European Union (EU) for the 1st-line maintenance treatment of patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the Phase III POLO trial, which were published in The New England Journal of Medicine.

The trial demonstrated that Lynparza nearly doubled the time patients with gBRCAm metastatic pancreatic cancer lived without disease progression or death to a median of 7.4 months versus 3.8 months on placebo. The safety and tolerability profile of Lynparza in the POLO trial was consistent with previous trials.

José Baselga, Executive Vice President, Oncology R&D, said: “Patients with advanced pancreatic cancer have seen limited treatment advances over the last few decades. We are now one step closer to bringing the first targeted medicine to certain biomarker-selected patients with advanced pancreatic cancer in the EU.”

Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: “A pancreatic cancer diagnosis is devastating, and we are committed to research that aims to change the prognosis for patients. The POLO Phase III trial demonstrated that treatment with Lynparza extended time without disease progression in certain patients with advanced pancreatic cancer – we are hopeful that we will be able to bring this treatment to patients in the EU soon.”

The CHMP recommendation is for maintenance treatment with Lynparza for adult patients with germline BRCA1/2 mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a 1st-line  chemotherapy regimen.

Lynparza is approved in the US and several other countries as a 1st-line maintenance treatment for patients with gBRCAm metastatic pancreatic cancer based on the Phase III POLO trial, with ongoing regulatory reviews in the EU and other jurisdictions.

Lynparza was recently approved in the US for patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer. It was also approved in the US as a 1st-line maintenance treatment with bevacizumab for patients with homologous recombination deficiency (HRD)-positive advanced ovarian cancer.