Prostate Cancer Drug Granted Breakthrough Therapy Designation

The FDA granted Breakthrough Therapy Designation for oral poly ADP-ribose polymerase (PARP) inhibitor to help in the treatment of prostate cancer.

AstraZeneca’s olaparib (Lynparza) is a first in class PARP inhibitor for the monotherapy treatment of patients with BRCA 1/2 or ATM gene mutated metastatic castration resistant prostate cancer (mCRPC) who received prior chemotherapy and 1 or more of the hormonal agents, abiraterone or enzalutamide.

This inhibitor exploits tumor DNA repair pathway deficiencies in order to kill cancerous cells.

The FDA granted breakthrough designation following results of the phase 2 TOPARP-A trial, which found that olaparib could offer an improved treatment option over already available therapies. Researchers found that men with prostate cancer who had defective DNA damage repair mechanisms responded positively to Lynparza.

The results of the trial were published in the New England Journal of Medicine in October 2015.

“More than 27,000 men died of prostate cancer last year in the US alone,” said AstraZeneca Head of Oncology Antoine Yver, MD. “The Breakthrough Therapy designation for Lynparza is encouraging news for patients, and their families, as there are currently very limited treatment options for metastatic Castration Resistant Prostate Cancer. We will work closely with the FDA to introduce Lynparza as a new treatment option as soon as possible.”

Once the prostate cancer has progressed to mCPRPC, physicians focus on extending the patient’s life by delaying progression and improving quality of life. For patients who received chemotherapy and newer hormonal agents, the overall survival rate is 10 months.

Lynparza has been approved in 40 countries for women with BRCA mutated ovarian cancer. AstraZeneca is currently looking at how Lynparza would work on other PARP dependent tumors. Also phase 3 studies in gastric cancer, pancreatic cancer, and adjuvant and metastatic BRCAm breast cancers are currently underway.