FDA Pipeline: Priority Reviews in Prostate Cancer, Mantle Cell Lymphoma
This week, the U.S. Food and Drug Administration (FDA) accepted new drug applications for enzalutamide in metastatic hormone-sensitive prostate cancer and zanubrutinib in relapsed or refractory mantle cell lymphoma, and granted both applications Priority Review.
Priority Review for Enzalutamide in Metastatic Hormone-Sensitive Prostate Cancer
The FDA accepted a supplemental new drug application for enzalutamide in the treatment of men with metastatic hormone-sensitive prostate cancer. The application has also been granted Priority Review. The FDA has set a Prescription Drug User Fee Act date, or target action date, for late 2019. Enzalutamide, a nonsteroidal antiandrogen, is currently indicated in the United States for the treatment of patients with castration-resistant prostate cancer.
The submission is based on results from the phase III ARCHES trial presented at the 2019 Genitourinary Cancers Symposium and published in the Journal of Clinical Oncology. The study evaluated the efficacy and safety of enzalutamide plus androgen-deprivation therapy (ADT) vs ADT plus placebo in men with metastatic hormone-sensitive prostate cancer. The primary endpoint of radiographic progression-free survival was met in the study. Additionally, the submission is supported by data from the phase III ENZAMET trial. The ENZAMET trial evaluated enzalutamide plus ADT vs ADT plus a standard nonsteroidal antiandrogen therapy (bicalutamide, nilutamide or flutamide) in men with metastatic hormone-sensitive prostate cancer to provide an active control. The results were presented during the Plenary Session at the 2019 ASCO Annual Meeting and simultaneously published in The New England Journal of Medicine. The primary endpoint of overall survival was met in the ENZAMET trial. The safety analyses of the ARCHES and ENZAMET trials appear consistent with the safety profile of enzalutamide in previous clinical trials in castration-resistant prostate cancer.
Data from the ARCHES and ENZAMET studies have also been submitted to the European Medicines Agency and to the Pharmaceuticals and Medical Devices Agency in Japan to potentially support an indication for enzalutamide that includes men with metastatic hormone-sensitive prostate cancer.
Priority Review for Zanubrutinib in Relapsed or Refractory Mantle Cell Lymphoma
The FDA also accepted a new drug application for zanubrutinib in patients with mantle cell lymphoma who have received at least one prior therapy. The FDA granted the application Priority Review and has set a Prescription Drug User Fee Act target action date of February 27, 2020. This follows the FDA’s Breakthrough Therapy designation for zanubrutinib in this setting earlier this year.
Zanubrutinib is an investigational small molecule inhibitor of Bruton’s tyrosine kinase.
The application was supported by data from a global phase I/II trial (NCT02343120) in patients with B-cell lymphomas, an aggregate of 123 patients in a multicenter phase II trial of zanubrutinib in patients with relapsed or refractory mantle cell lymphoma in China (NCT03206970), as well as safety data on 641 patients from five clinical trials and nonclinical data.
A new drug application for zanubrutinib in relapsed or refractory mantle cell lymphoma has also been accepted by the China National Medical Products Administration and granted Priority Review.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
