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.
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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.
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By GlobalDataThe 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.
