# AstraZeneca’s Lynparza receives EU approval for pancreatic cancer

- Link: https://www.directorstalkinterviews.com/astrazenecas-lynparza-receives-eu-approval-for-pancreatic-cancer/412840326
- Published: 2020-07-08T07:18:56+01:00
- Author: Amilia Stone

**[AstraZeneca plc](https://www.directorstalkinterviews.com/ftse-company/astrazeneca/azn.l)**(
[LON:AZN](https://www.directorstalkinterviews.com/ftse-company/astrazeneca/azn.l))
and MSD Inc., Kenilworth, N.J., US (known as Merck & Co., Inc. inside the US and
Canada) have announced that _Lynparza_  has been approved in the European Union (
EU) for patients with germline BRCA-mutated metastatic pancreatic cancer.

Pancreatic cancer is a rare, life-threatening disease with the lowest survival rate
among the most common cancers.^(1) Approximately 5-7% of patients with metastatic
pancreatic cancer have a germline BRCA mutation.^(2)

The approval by the European Commission was based on results from the Phase III 
POLO trial, which were published in The New England Journal of Medicine_._ It follows
the recommendation for approval by the Committee for Medicinal Products for Human
Use of the European Medicines Agency.

> **Hedy L. Kindler, Co-Principal Investigator of the POLO trial and Professor of
> Medicine, University of Chicago Medicine, said: **“Today’s approval opens the 
> door to a new era of biomarker-led care for patients with metastatic pancreatic
> cancer in the EU, which has the highest incidence of any region globally. _Lynparza_
> now provides clinicians with a targeted, well-tolerated treatment option for patients
> with germline BRCA-mutated metastatic pancreatic cancer.”

> **Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: **“
> Patients with metastatic pancreatic cancer historically have faced poor outcomes
> due to the aggressive nature of the disease and few treatment advances have been
> made over the last few decades. In the POLO trial, _Lynparza_ nearly doubled median
> progression-free survival versus placebo after 1st-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.”

> **Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief
> Medical Officer, MSD Research Laboratories, said: **“MSD and AstraZeneca are committed
> to advancing research into the treatment of patients with challenging types of
> cancer, including those with metastatic pancreatic cancer. _Lynparza_ is now the
> only approved PARP inhibitor in biomarker-selected patients with metastatic pancreatic
> cancer. We look forward to making this targeted treatment option available for
> patients across the EU as quickly as possible.”

The POLO 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 trial was consistent with previous trials.

_Lynparza_ is indicated as monotherapy for the maintenance treatment of 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 other regions.

Share on: