Home Urology / Nephrology FDA Approves Apalutamide for Metastatic Castration-Sensitive Prostate Cancer

FDA Approves Apalutamide for Metastatic Castration-Sensitive Prostate Cancer


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

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

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

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