Approval will open new treatment option for more than 70,000 patients each year in the EU 

The European Committee for Medicinal Products for Human Use today recommended the use of abiraterone acetate (Zytiga) for patients with advanced prostate cancer throughout European Union member states. Final approval by the European Commission, considered widely to be a formality, is expected within just weeks.

PCF funded more than $8 million for early research that helped answer leading questions about the drug including how it works and its role in advanced metastatic prostate cancer. The Foundation also helped speed clinical trials through its Prostate Cancer Clinical Trials Consortium, enrolling more men into abiraterone trials faster than any previous prostate cancer drug study. PCF is supporting continuing research to assess in which patients Zytiga is most effective, potential benefits to patients if the drug is deployed earlier in the disease process, as wells as what other drugs Zytiga might be combined with to further improve patient outcomes.

Marketed by Johnson & Johnson under the name Zytiga, abiraterone was approved for patient use by the U.S. Food and Drug Administration in April of this year. According to the European Society for Medical Oncology, nearly 70,000 European men are expected to die of prostate cancer in 2011. Coupled with the projection of 33,000 annual deaths in the United States, these two government approvals mean that more than 100,000 patients, who are most in need of advanced treatments each year, will ultimately have access to this promising new drug.

As reported in today’s Daily Mail, during Phase III clinical trials involving almost 800 patients in 13 countries, Zytiga, combined with conventional steroid treatment, provided a median survival of 15 months compared with 11 months on steroids alone. During these trials, patient response was so promising and so few serious side effects were reported that patients who were in the placebo arm were given the option of being treated with Zytiga.

“We are thrilled that the regulator has recommended Zytiga be granted marketing approval throughout Europe,” said Johann de Bono, MD, PhD, at the U.K.-based Institute of Cancer Research and an investigator funded by the Prostate Cancer Foundation (PCF).”Men with metastatic prostate cancer have very few treatment options available to them and new therapies such as this are desperately needed.”

One proviso for European residents: once the European Commission provides the final green light for Zytiga, access in individual countries will be subject to insurance reimbursement policies in each member nation. For instance, in the U.K., the Government watchdog, NICE, will need to review the drug’s benefits before ruling whether it should be prescribed by the National Health Service, a process that could take several years. Until then, patients would have to pay for it privately or apply for funding from the Cancer Drugs Fund or Primary Care Trust. Once the drug is approved, EU nationals should check with their physicians to determine reimbursement policies and the best means for attaining coverage.