FDA approves Erleada for the treatment of patients with metastatic castration-sensitive prostate cancer. Johnson & Johnson

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the FDA has approved Erleada (apalutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). The approval follows FDA Priority Review Designation of the supplemental New Drug Application (sNDA) that was submitted in April 2019 and reviewed through the FDA Real-Time Oncology Review program. The new indication for Erleada will make this androgen receptor inhibitor available for the approximately 40,000 people in the U.S. diagnosed with mCSPC annually.

Approval is based on results from the Phase III TITAN study, which achieved statistical significance in the dual primary endpoints of overall survival (OS) and radiographic progression-free survival (rPFS) at the first pre-planned interim analysis. The trial recruited patients regardless of extent of disease, including both high- and low- volume disease, or prior docetaxel treatment history. Results were presented in an oral session at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in The New England Journal of Medicine.

In the TITAN study, Erleada plus ADT significantly extended OS compared to placebo plus ADT with a 33 percent reduction in the risk of death (HR=0.67; 95 percent CI, 0.51-0.89; P=0.0053). Erleada plus ADT also significantly improved rPFS compared to placebo plus ADT with a 52 percent lower risk of radiographic progression or death (HR=0.48; 95 percent CI, 0.39-0.60; P<0.0001).1 as reported in the published results from the titan study the two-year os rates after a median follow-up of 22.7 months were 84 percent for erleada plus adt compared to 78 percent for placebo plus adt. the most common adverse reactions 10 percent that occurred more frequently in erleada treated patients greater than2 percent over placebo from the randomized placebo-controlled clinical trials titan and spartan were fatigue arthralgia rash decreased appetite fall weight decreased hypertension hot flush diarrhea and fracture.>

See- "Apalutamide for Metastatic, Castration-Sensitive Prostate Cancer"-Kim N. Chi, M.D., Neeraj Agarwal, M.D., Anders Bjartell, M.D., Byung Ha Chung, M.D., Andrea J. Pereira de Santana Gomes, M.D., Robert Given, M.D., �lvaro Ju�rez Soto, M.D., Axel S. Merseburger, M.D., Mustafa �zg�ro?lu, M.D., Hirotsugu Uemura, M.D., Dingwei Ye, M.D., Kris Deprince, M.D., et al., for the TITAN Investigators-July 4, 2019. N Engl J Med 2019; 381:13-24 DOI: 10.1056/NEJMoa1903307