Lynparza secures CHMP recommendation in first-line BRCA-mutated metastatic pancreatic cancer

pharmafile | June 1, 2020 | News story | Sales and Marketing AstraZeneca, Cancer, MSD, Pancreatic cancer, lynparza 

Lynparza (olaparib), the PARP inhibitor developed by AstraZeneca and MSD, has just secured recommendation for approval from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) as a first-line maintenance treatment for germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer.

The advice relates specifically to patients who have not seen their disease progress after receiving a minimum of 16 weeks of first-line platinum chemotherapy.

The Committee’s decision was based on new Phase 3 data in which Lynparza was shown to almost double progression-free survival in participants with gBRCAm metastatic pancreatic cancer compared to placebo from 3.8 months to 7.4 months.

“A pancreatic cancer diagnosis is devastating, and we are committed to research that aims to change the prognosis for patients,” commented Roy Baynes, MSD’s Senior Vice President and Head of Global Clinical Development and Chief Medical Officer, on the news.  “The POLO Phase 3 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.”

While the European Commission, which will make the final approval decision shortly, is not beholden to the Committee’s opinion, it often follows its guidance. Lynparza recently secured approval in the US from the FDA for homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer, as well as a first-line maintenance treatment for homologous recombination deficiency (HRD)-positive advanced ovarian cancer when combined with bevacizumab.

Matt Fellows

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