TGA approves AstraZeneca’s targeted therapy in advanced prostate cancer

Pharma News: AstraZeneca Australia announced the Therapeutic Goods Administration (TGA) approval of its PARP inhibitor for the treatment of adult patients with BRCA-mutated metastatic castration-resistant prostate cancer who have progressed following prior therapy that included a new hormonal agent.

A daily oral medicine, Lynparza (olaparib) is the first targeted treatment for men with BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC0. For men living with aggressive BRCA-mutated metastatic prostate cancer which is still progressing on hormone therapy, there are limited treatment options in Australia, unlike women living with BRCA-mutated cancers, for whom there are several treatment options.

Associate Professor Shahneen Sandhu of Peter MacCallum Cancer Centre, said, “mCRPC is a lethal disease with a substantial impact on patients’ survival, and quality of life. Lynparza represents the first ever personalised therapy for men with mCRPC who have an underlying BRCA1/2 alteration and will provide an additional treatment option for these men. I look forward to the day when molecular testing and personalisation of treatment becomes routine practice.”

Professor Jeff Dunn AO, CEO of Prostate Cancer Foundation of Australia, welcomed the news. “This is a significant step forward for hundreds of Australian men and families who are living with advanced prostate cancer. We are extremely pleased to see Australian authorities supporting the registration of new treatments for these men. We commend AstraZeneca for its commitment to funding discoveries such as this.”

There is currently an application with Medical Services Advisory Committee (MSAC) for testing of tumour prostate tissue to detect BRCA1/2 or ATM gene mutations in men with mCRPC to determine eligibility for treatment with Lynparza.

The Pharmaceutical Benefits Advisory Committee (PBAC) meeting outcomes from the March 2021 meeting did not recommend Lynparza for PBS listing saying “Although olaparib demonstrated clinical benefit in patients with BRCA1/2 gene variants, the nominated comparator did not reflect current Australian clinical practice which meant that the economic evaluation was highly uncertain.”

Liz Chatwin, Country President, AstraZeneca Australia & New Zealand, said “Lynparza has been available to women in Australia and around the world, living with and impacted by BRCA mutated ovarian and breast cancers, for several years now. We are delighted that Lynparza is now available for eligible men in Australia living with BRCAm prostate cancer, who until now have had limited treatment options. AstraZeneca is committed to working promptly with the Pharmaceutical Benefits Advisory Committee to seek PBS reimbursement for Lynparza in this setting.”

AstraZeneca also expects that sometime this year the data from the phase 3 PROpel trial is released, which tests Lynparza plus Janssen’s Zytiga against Zytiga monotherpay in previously untreated metastatic castration-resistant prostate cancer.

Prostate cancer is the most common cancer diagnosed in men and the second most common cause of cancer death in Australia. One in six men will be diagnosed with prostate cancer by the age of 85. It is more common in older men, with over 63% of cases diagnosed in men over 65 years of age.

By 2040, it is predicted there will be 372,000 men living with prostate cancer, or in remission, in Australia.