FDA fast tracks Bayer prostate cancer drug
pharmafile | August 23, 2011 | News story | Sales and Marketing | Algeta, Alpharadin, Bayer, prostate cancer
Bayer’s potential blockbuster prostate cancer drug Alpharadin has been granted a fast track review by the FDA, meaning it could be approved within six months.
Bayer is seeking a license for Alpharadin (radium-223 chloride) to be used to treat castration-resistant (hormone refractory) prostate cancer in patients with bone metastases.
Fast track status is awarded to drugs that treat serious diseases or fill an unmet medical need and, by speeding up the normal review process, usually means such drugs are approved within six to ten months.
Kemal Malik, head of global development Bayer, said: “We are excited that Alpharadin has achieved this important milestone and recognise this fast track designation as an important step in the overall development of Alpharadin, particularly for those patients in need of treatment.”
Analysts expect its revenue potential to be between €500 million and €1.2 billion ($717.9 million to $1.7 billion) in peak annual sales.
In June the drug’s pivotal phase III ALSYMPCA trial, which evaluated Alpharadin in patients with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases, proved successful enough to be stopped early.
The trial showed that the overall survival (OS) result – the gold standard endpoint in all cancer trials – was statistically significant, with the median OS being 14 months for Alpharadin, and 11.2 months for placebo.
Alpharadin is an investigational alpha-pharmaceutical (a drug containing an alpha-particle emitting nuclide), which mimics many of the behaviours of calcium in the bone.
In 2009 Bayer exclusively licensed the drug from Norwegian firm Algeta ASA. Under the terms of the agreement, Bayer will develop, apply for global approvals, and commercialise Alpharadin globally, while Algeta retains an option for up to fifty-fifty co-promotion and profit sharing in the US.
Andrew Kay, Algeta’s president and chief executive, said: “The positive results […] of the pivotal phase III study, ALSYMPCA, was a great achievement for Algeta and for Bayer, reinforcing the common belief of Alpharadin’s potential to become an important treatment for bone metastases initially with prostate cancer.”
Currently J&J’s Zytiga and Sanofi’s Jevtana are approved in the US to treat advanced forms of castration-resistant prostate cancer, but neither are licenced for CRPC in patients with bone metastases.
Ben Adams
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