Sunday, November 4, 2018

Judge rules patent on Zytiga® invalid


CANCER DIGEST – Nov. 4, 2018 – A federal judge in New Jersey has ruled that Johnson & Johnson’s patent for the anti-prostate cancer drug abiraterone is invalid. The decision clears the way for generic versions of the drug, which are under development by a number of pharmaceutical companies. 

In February the FDA approved abiraterone acetate (Zytiga®) in combination with prednisone for patients with high-risk disease based on phase III findings from the LATITUDE study.

In the trial, the combination of abiraterone acetate and androgen deprivation therapy (ADT) led to a 38 percent reduction in the risk of death compared with ADT alone.

After a follow-up of 30.4 months, median overall survival (OS) was not yet reached with abiraterone acetate compared with 34.7 months with placebo for patients with high-risk metastatic castration-sensitive prostate cancer.

The judge's ruling could result in lowering the estimated $5,000 per month cost of treatment with Zytiga.


Sources: Cancer Discovery News of the AACR and FDA press release


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