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Erleada FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 19, 2019.

FDA Approved: Yes (First approved February 14, 2018)
Brand name: Erleada
Generic name: apalutamide
Dosage form: Tablets
Company: Janssen Pharmaceuticals, Inc.
Treatment for: Prostate Cancer

Erleada (apalutamide) is an oral androgen receptor inhibitor for the treatment of metastatic castration-sensitive prostate cancer, and non-metastatic castration-resistant prostate cancer.

Development timeline for Erleada

DateArticle
May  3, 2024Phase 2 data for Erleada plus androgen deprivation therapy following radical prostatectomy in patients with high-risk localized prostate cancer results published
Jan 31, 2024First Patient Dosed in Phase 2 Trial of ENV105 with Apalutamide to Improve Therapy Sensitivity for Castrate-Resistant Prostate Cancer
Apr 12, 2023ESSA Pharma Announces Clinical Trial Support Agreement with Janssen to Evaluate EPI-7386 Combinations in Patients with Prostate Cancer
Sep 17, 2019Approval FDA Approves Erleada (apalutamide) for the Treatment of Patients with Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
Feb 14, 2018Approval FDA Approves Erleada (apalutamide) for Non-Metastatic Castration-Resistant Prostate Cancer
Oct 11, 2017Janssen Submits New Drug Application to U.S. FDA for Apalutamide (ARN-509) to Treat Men with Non-Metastatic Castration-Resistant Prostate Cancer

See also

Erleada (apalutamide) Consumer information

Further information

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