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AZ, Merck win FDA approval for Lynparza in pancreatic cancer

New treatment option for subset of patients with BRCA-mutations


AstraZeneca and partner Merck & Co/MSD can now add pancreatic cancer to the growing list of cancers targeted by their PARP inhibitor Lynparza, following a green-light from the FDA.

Lynparza (olaparib) has been approved in the US as a first-line maintenance therapy for metastatic pancreatic cancer patients who carry BRCA mutations.

It will now become available to patients with pancreatic cancer, whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy treatment regimen.

Pancreatic cancer is characteristically tough-to-beat, and carries poor survival rates – less than 7% of patients are still alive five years after diagnosis. It is also notoriously difficult to target, and so is severely lacking in new treatment options.

Around 5% to 6% of pancreatic cancers are caused by mutations in one or both BRCA genes, which are more commonly associated with ovarian and breast cancers.

“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 Dave Fredrickson, executive vice president, oncology business unit, AZ.

“Lynparza is now the only approved targeted medicine in biomarker-selected patients with advanced pancreatic cancer,” he added.

The approval was based on results from the phase 3 POLO study of Lynparza. In a study population consisting of advanced BRCA-mutated pancreatic cancer patients, Lynparza demonstrated an impressive progression-free survival rate of 7.4 months compared to 3.8 months for the placebo group.

After two years, 22.1% of those on the PARP inhibitor had no disease progression, compared to only 9.6% of those treated with placebo.

“Metastatic pancreatic cancer patients have been waiting a long time for new therapy options for their devastating disease,” said Julie Fleshman, president and CEO of Pancreatic Cancer Action Network.

“Today’s approval of Lynparza provides an exciting new treatment option for patients with germline BRCA-mutated metastatic pancreatic cancer,” she added.

Lynparza is already approved as a treatment for ovarian, fallopian tube, primary pertioneal and BRCA-mutated HER2-negative breast cancer.

Although this form of pancreatic cancer is fairly small in terms of eligible patients, Lynparza is the first PARP inhibitor to show efficacy in this indication.

The approval will help AZ and Merck to maintain a lead over newer rivals in the class, including GlaxoSmithKline’s Zejula (niraparib) and Clovis Oncology’s Rubraca (rucaparib).

PARP inhibitors work by blocking what is left of DNA repair mechanisms, which causes cancer cells to fail to replicate, meaning tumours cannot survive.

Article by
Lucy Parsons

2nd January 2020

From: Regulatory



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