A Generic Version of Zytiga Has Been Approved by the FDA

It has just been announced yesterday that the U.S. Food and Drug Administration (FDA) has approved a generic version of Zytiga, the new drug’s name is Yonsa.  It is a novel formulation of abiraterone acetate that needs to be used in combination with methylprednisolone for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC).

The announcement by Abhay Gandhi, CEO - North America, Sun Pharma read, “We are pleased to add Yonsa to our growing oncology portfolio and continue to deliver on Sun Pharma’s commitment for enhanced patient access to innovative cancer therapies.”

Like Zytiga, Yonsa is a CYP17 inhibitor, but it uses proprietary SoluMatrix Fine Particle Technology™ to create a micronized (smaller particle size) formulation of abiraterone acetate tablets that needs to be used in combination with methylprednisolone. The active ingredient is converted in vivo to abiraterone, an androgen biosynthesis inhibitor that inhibits 17 α-hydroxylase/C17,20-lyase (CYP17). The CYP17 enzyme is expressed in testicular, adrenal and prostatic tumor tissues and is required for androgen biosynthesis.

 Because of the fine particle technology used in this new drug a person taking it needs to avoid substitution errors which could lead to overdoses.  Yonsa tablets may have different dosing and food effects than other abiraterone acetate products like Zytiga. Like Zytiga, men receiving Yonsa should also receive a gonadotropin-releasing hormone (GnRH) analog9like Lupron) concurrently or should have had bilateral orchiectomy.

Joel T. Nowak, MA, MSW wrote this Post.  Joel is the CEO/Executive Director of Cancer ABCs.  He is a Cancer Thriver diagnosed with five primary cancers - Thyroid, Metastatic Prostate, Renal, Melanoma, and the rare cancer Appendiceal cancer.