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EU gives AZ’s Lynparza green light for BRCA-mutated pancreatic cancer

PARP inhibitor now available for rare, life-threatening disease


The European Commission has approved AstraZeneca (AZ) and Merck/MSD’s PARP-inhibitor Lynparza for the treatment of patients with BRCA-mutated metastatic pancreatic cancer.

The approval was based on results from the phase 3 POLO trial of Lynparza (olaparib) in advanced pancreatic cancer patients whose tumours carry BRCA mutations. About 5-7% of metastatic pancreatic cancers are caused by mutations in one or both BRCA genes, which are commonly associated with ovarian and breast cancer but can be seen in a number of tumour types.

In the POLO trial, Lynparza or placebo was given to patients whose cancer had not progressed after completion of initial platinum-based chemotherapy. Participants treated with AZ’s drug demonstrated a progression-free survival rate of 7.4 months, which was almost twice the 3.8 months observed in the placebo group. After two years of treatment with Lynparza, 22.1% had no disease progression, compared to 9.6% of those treated in the placebo arm.

“Patients with metastatic pancreatic cancer have historically faced poor outcomes due to the aggressive nature of the disease and few treatment advances have been made over the last few decades,” said Dave Fredrickson, executive vice president, AZ’s oncology business unit.

“In the POLO trial, Lynparza nearly doubled median progression-free survival versus placebo after first-line chemotherapy for patients with germline BRCA-mutated metastatic pancreatic cancer. This approval underscores the importance of testing all patients for germline BRCA mutations at the time of diagnosis, as it will help inform personalised treatment options for patients in the EU,” he added.

On 30 December last year, the US Food and Drug Administration (FDA) approved AZ's Lynparza for the same pancreatic cancer indication, and has also been approved as a treatment for ovarian, fallopian tube, primary pertioneal and BRCA-mutated HER2-negative breast cancer.

Although this form of pancreatic cancer has a fairly small number of eligible patients, Lynparza is the first PARP inhibitor to show efficacy in this particular indication. That includes GlaxoSmithKline’s (GSK) Zejula (niraparib) and Clovis Oncology’s Rubraca (rucaparib).

GSK’s Zejula is more of a threat to Lynparza in the ovarian cancer market, with both companies revealing positive results for the respective drugs in this cancer type last year. Despite this increasing competition, Lynparza is still the undisputed leader in the PARP-inhibitor category, having brought in $351m in AZ’s fourth quarter results.

The new approval in the EU will help  this growth continue in 2020, with AZ likely to rely more on its established drug brands due to disruption from the ongoing COVID-19 pandemic.

Article by
Lucy Parsons

8th July 2020

From: Regulatory



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