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FDA Approves New Abiraterone Acetate Formulation for mCRPC

Silas Inman @silasinman
Published: Wednesday, May 23, 2018

The FDA has approved a new formulation of abiraterone acetate (Yonsa) in combination with methylprednisolone as a treatment for men with metastatic castration-resistant prostate cancer (mCRPC), according to Sun Pharma, the company commercializing the treatment.

Abiraterone acetate (Zytiga) was initially approved as a treatment for men with mCRPC following chemotherapy. It subsequently gained approval for use prior to chemotherapy. In February 2018, Zytiga was approved in combination with prednisone for patients with metastatic high-risk castration-sensitive prostate cancer.
Stein CA, Levin R, Given R, et al. Randomized phase 2 therapeutic equivalence study of abiraterone acetate fine particle formulation vs. originator abiraterone acetate in patients with metastatic castration-resistant prostate cancer: The STAAR study. Urol Oncol. 2018;36(2):81e9-81.e16.

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