Johnson and Johnson Prostate Cancer Drug ZYTIGA™ (Abiraterone Acetate) Receives FDA Approval

For a little back history a study announced in October of 2010 the drug prolonged life for an average of 4 months.  You can read the entire press release and additional information at the links in the web pages below.  In order to be prescribed, patients must be in the category of having received prior chemotherapy treatment. 

J&J Prostate Cancer Drug Found to Prolong Life for an Average of 4 Months–Competition for Provenge?

In addition during the opening of the new MIT Cancer Center David Koch also talked about his diagnosis of prostate cancer and his treatment with the drug, and it appears the video of the dedication has been removed when I went back to look.

David Koch Institute For Integrative Cancer Opened at MIT-Better to Invest and Donate to Healthcare Research Than Politics

Back in May of 2009, Johnson and Johnson acquired Cougar Biotech in Los Angeles and now it has been incorporated into the Centocor Ortho Biotech division of Johnson and Johnson.

Johnson and Johnson Acquiring Cougar Biotechnology – Cancer Biotech Company Los Angeles

From the website:

“ZYTIGA (abiraterone acetate) was developed by Ortho Biotech Oncology Research & Development, a Unit of Cougar Biotechnology, Inc., and will be marketed by Centocor Ortho Biotech Inc. Marketing applications for ZYTIGA have been filed with other regulatory authorities throughout the world.

ZYTIGA is the first oral, once-daily medication indicated for use in combination with prednisone for the treatment of men with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel. For more information about ZYTIGA, visit www.ZYTIGA.com.”

Back when the acquisition was made by J and J there was a lot of discussion of purchasing a company with pipeline only and nothing on the market yet, as being a bit of a gamble, but that changed today with the FDA approval.  The good news for patients is that the treatment is simple with taking one pill every day. 

There’s no mention on the specific cost but it seemed to circle right around $5000 a month, and recently in the news Medicare had approved another “very expensive” prostate cancer drug, Provenge that extends life and it’s a whole different class of drug with a very different treatment plan requiring injections so one does wonder how cost will come into the picture here when the 2 are compared as just common sense tells me with being a pill versus the Provenge treatment that it should be less expensive and it would be obviously more convenient for the patient.  Both drugs are pretty much the same on how long life is extended.   I am guessing here too the next step is for CMS/Medicare approval for the drug which if they approved Provenge this should not be an issue.  BD   

Horsham, Pa., April 28, 2011 /PRNewswire/ — Centocor Ortho Biotech Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved ZYTIGA™ (abiraterone acetate), an oral, once-daily medication for use in combination with prednisone for the treatment of men with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel.

Androgens are hormones that promote the development and maintenance of male sex characteristics. However, in prostate cancer, androgens can help fuel the tumor’s growth. Androgen production primarily occurs in the testes and adrenal glands; in men with prostate cancer, the tumor tissue is an additional source of androgens. ZYTIGA is an oral androgen biosynthesis inhibitor that works by inhibiting the CYP17 enzyme complex, which is required for the production of androgens at these three sources.

“This FDA approval represents a welcome new option in the treatment of metastatic prostate cancer,” said Howard Scher, MD, Chief of the Genitourinary Oncology Service, Sidney Kimmel Center for Urologic and Prostate Cancers at Memorial Sloan-Kettering, and one of the co-lead investigators for the Phase 3 clinical study. “As a clinician, I believe the efficacy and safety profile of abiraterone acetate, as well as its oral, once-daily formulation, will help address the important need for additional therapeutic choices for men living with this serious disease.

ZYTIGA™ (abiraterone acetate) RECEIVES FDA APPROVAL FOR TREATMENT OF METASTATIC PROSTATE CANCER AFTER PRIORITY REVIEW

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