Apalutamide has received FDA marketing clearance for the treatment of metastatic castration-sensitive prostate cancer (mCSPC).

FDA based its approval on findings from the phase 3 TITAN trial. In that trial, which included 1052 men with mCSPC, those who received apalutamide plus androgen deprivation therapy (ADT) had a significant 33% decreased risk of death and 52% decreased risk of radiographic progression or death compared with those who received placebo and ADT. After a median follow-up period of 22.7 months, the 2-year overall survival rates were 84% in the apalutamide arm compared with 78% for the placebo recipients.

Investigators presented TITAN trial findings at the 2019 American Society of Clinical Oncology annual meeting and published those findings simultaneously in The New England Journal of Medicine.

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In a press release from Jansen Pharmaceutical Companies of Johnson & Johnson, the makers of apalutamide, Kim Chi, MD, of BC Cancer and Vancouver Prostate Centre in Vancouver, British Columbia, and principal investigator on the TITAN trial stated: “Results from the TITAN study showed that, regardless of the extent of disease, patients with metastatic castration-sensitive prostate cancer have the potential to benefit from treatment with apalutamide in addition to ADT.”


U.S. FDA approves Supplement New Drug Application (sNDA) for ERLEADA (apalutamide for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). Janssen Pharmaceutical press release. September 17, 2019. https://www.janssen.com/us/sites/www_janssen_com_usa/files/u.s._fda_approves_snda_for_erleada_apalutamide_for_the_treatment_of_patients_with_metastatic_castration-sensitive_prostate_cancer_mcspc.pdf

Chi KN, Agarwal N, Bjartell A, et al. Apalutamide for metastatic, castration-sensitive prostate cancer. N Engl J Med. 2019;381:13-24. doi: 10.1056/NEJMoa1903307