AstraZeneca and Merck (MSD) have received conditional approval from Health Canada for Lynparza (olaparib) plus abiraterone and prednisone or prednisolone to treat prostate cancer.

According to the Notice of Compliance with Conditions (NOC/c) granted by Health Canada, the treatment is indicated for adults with deleterious or suspected deleterious germline and/or somatic BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC), who are not eligible for chemotherapy. 

The latest development is based on findings from the Phase III PROpel clinical trial, which met the pre-specified primary endpoint. 

The multicentre, double-blind, randomised, placebo-controlled trial evaluated the safety, efficacy and tolerability of Lynparza along with abiraterone versus placebo with abiraterone in male mCRPC patients. 

In both treatment groups, subjects also received either prednisone or prednisolone twice a day.

The subgroup’s assessment showed that treatment with Lynparza plus abiraterone demonstrated improvement in radiographic progression-free survival versus placebo and abiraterone.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The combination treatment’s tolerability and safety in the trial were consistent with that reported in previous studies and in the observed profiles of the individual therapies. 

Lynparza is an oral inhibitor of polyadenosine diphosphate-ribose polymerase which has obtained approval for treating ovarian, breast, pancreatic and other cancers in Canada.

In June 2023, the companies received approval from the US Food and Drug Administration for Lynparza plus standard therapies for mCRPC.