FDA Grants Breakthrough Therapy for AstraZeneca’s Lynparza
AstraZeneca reports that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) for the oral poly ADP-ribose polymerase (PARP) inhibitor, Lynparza (olaparib), for a specific indication to treat certain types of prostate cancer. It was granted breakthrough therapy status as amonotherapy treatment of BRCA1/2 or ATM gene-mutated metastatic castration-resistant prostate cancer in patients who have received a prior taxane-based chemotherapy and at least one newer hormonal agent (abiraterone or enzalutamide).
The breakthrough therapy designation for Lynparza in this patient population means the FDA will expedite review of submission data within 60 days of receipt.
Lynparza has been approved by regulatory authorities in 40 countries for the maintenance treatment of women with BRCA-mutated ovarian cancer. AstraZeneca is investigating the potential of olaparib in other PARP- dependent tumors. Phase III studies in gastric cancer, pancreatic cancer and adjuvant and metastatic BRCAm breast cancers are underway, with further studies planned.