Yesterday, Johnson & Johnson announced that it has asked U.S. and European Union regulators to grant broader marketing approval for its cancer pill, Zytiga which is used to treat men with castrate resistant prostate cancer.
Zytiga was approved in 2011 for the treatment of advanced prostate cancer in men who have received chemotherapy and who were castrate resistant. Johnson & Johnson said it asked regulators to approve Zytiga for men who with castrate resistant prostate cancer but have not yet been treated with chemotherapy and who have few or no symptoms from their cancer.
Earlier this month Johnson & Johnson reported strong results from a clinical trial involving men who had received hormone treatment and not chemotherapy. The company said Zytiga doubled the amount of time patients lived without their cancer getting worse.
Currently, there are many men who have been taking Zytiga “off label”, or prior to there having chemotherapy. Those individuals I know who have managed to get Zytiga pre-chemotherapy have all done very well with little or no side effects.
I applaud this move and hope that the various regulatory agencies move to quickly approve this request.
Joel T Nowak, M.A., M.S.W.