Priority Review of Lynparza If Paired With Abiraterone In US

Priority consideration has been given to AstraZeneca’s supplemental new drug application for Lynparza (olaparib) when used in conjunction with abiraterone, prednisone, or prednisolone to treat elderly patients with advanced castration-resistant prostate cancer (mCRPC).

AstraZeneca and MSD, also known as Merck & Co. in the US and Canada and located in the UK, are working on developing and marketing Lynparza. Applications for drugs that demonstrate significant improvements in safety or efficacy, treat or prevent dangerous illnesses, or increase patient compliance are given priority assessment by the Food and Drug Administration (FDA).

Prostate cancer is the second most frequent disease in male patients in the US, and it is expected to result in over 35,000 fatalities in 2022. In clinical trial settings, the median survival time for patients with mCRPC is three years; in real-world situations, it is considerably less. Just one line of treatment response may be given to about half of mCRPC patients, and the effectiveness of additional medications will decrease over time.

Results from the PROpel phase 3 trial, which were reported at the 2022 American Society of Clinical Oncology Genitourinary Cancers Symposium, served as the basis for the new medication application. According to these findings, Lynparza and abiraterone together lowered the probability of disease progression or mortality by 34% in comparison to abiraterone alone.

There is a significant unfulfilled need for individuals diagnosed with metastatic castration-resistant prostate cancer, in which the diagnosis remains poor and therapy choices are restricted, said executive vice president, oncology R&D, AstraZeneca, Susan Galbraith. There is a further step toward introducing a brand-new, much needed therapy option in this situation. If authorized, Lynparza with abiraterone will be the first PARP inhibitor and novel hormone treatment to be used for this condition, the expert continued.

MSD is dedicated to discovering new treatments for people with metastatic castration-resistant prostate cancer, a complicated disease that urgently needs more therapies, said senior vice president, head of global clinical development and chief medical officer at MSD Research Laboratories, Dr. Eliav Barr. They are eager to collaborate with the FDA in order to provide patients with mCRPC, whether they have mutations in the HRR gene or not- with a new option.