Astellas seeks Xtandi extension
pharmafile | December 5, 2013 | News story | Sales and Marketing | Astellas, Cancer, EU, FDA, US, Xtandi
Astellas Pharma and development partner Medivation are seeking to extend the reach of oncology brand Xtandi by conducting a trial in patients with non-metastatic castration-resistant prostate cancer (CPRC).
The companies have enrolled the first patient in the global Phase III PROSPER trial looking at Xtandi (enzalutamide) in a population for whom there is no prescription drug specifically approved in the US.
“PROSPER targets an important patient population as we and Astellas look to advance the development of enzalutamide further upstream in the prostate cancer treatment paradigm,” said Medivation chief executive David Hung.
The novel androgen receptor inhibitor was approved in the US in 2012 and in the European Union earlier this year for the treatment of adult men with advanced prostate cancer – a group with relatively few existing therapy options.
The European authorisation was the trigger for Astellas to make a milestone payment of $15 million to Medivation.
The new trial programme will take 1,500 patients in the US, Canada, Europe, South America and Asia-Pacific region and compare Xtandi 160 mg taken once-daily versus placebo, plus androgen deprivation therapy.
Patients will be asymptomatic with no prior or present evidence of metastatic disease, and the primary endpoint is metastasis-free survival.
Xtandi is tipped to be a blockbuster, thanks to data showing it extended life of patients. Analysts forecast that it could earn $1-2 billion in peak sales and will provide competition to J&J’s Zytiga, which has been on the market since 2011.
In the Phase III AFFIRM study it decreased cancer cell growth and induced cancer cell death, giving patients in the trial a median survival time of 18.4 months – an increase of 4.8 months on those in the placebo arm.
The FDA approved the drug for patients with metastatic castration-resistant prostate cancer (mCRPC) who have previously received docetaxel.
Zytiga’s licence has been extended in Europe, which means the once-daily pill can now be used to treat mCRPC before chemotherapy.
Adam Hill
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