Mon Dec 10, 2012 5:16pm EST
(Reuters) – U.S. health regulators on Monday stretched a capitulation of Johnson Johnson’s drug Zytiga for modernized prostate cancer to concede a use before to diagnosis with chemotherapy.
The widely-expected, stretched Food and Drug Administration approval, that came after a association demonstrated that Zytiga could extend presence if used before to chemotherapy, is expected to significantly boost sales of a new medicine.
Wells Fargo Securities researcher Larry Biegelsen, in a investigate note progressing this year, foresee rise Zytiga sales of $2.3 billion in 2016, with about 70 percent entrance from pre-chemo use.
Zytiga was creatively authorized in Apr 2011 for use in multiple with a steroid prednisone to provide group whose prostate cancer had progressed following diagnosis with a chemotherapy drug docetaxel.
The pill, that works by dwindling prolongation of a hormone testosterone that fuels cancer growth, had sales of about $800 million in a initial year of availability, capturing some 60 percent of a post-chemotherapy market.
That marketplace share is expected to cringe due to new foe in a post-chemotherapy environment from Xtandi, that is sole by Medivation Inc and Astellas Pharma Inc, analysts said. Xtandi is still undergoing late theatre trials in patients who have not nonetheless perceived chemotherapy diagnosis and a drug could be a year or dual divided from a identical stretched approval.
However, Sanford Bernstein researcher Geoffrey Porges pronounced Xtandi was expected to advantage some “off label” use in pre-chemo patients. The tenure refers to doctors prescribing drugs for none-approved uses.
“Ultimately we are assured that Xtandi will get a allied or improved tag enlargement by midst 2014,” he said.
Meanwhile, Zytiga patients starts will get “an evident boost,” Porges added.
In late theatre clinical trials of some-more than 1,000 patients with modernized prostate cancer who had not been treated with chemotherapy, those who perceived Zytiga on normal lived some-more than 5 months longer than those who perceived a placebo.
“Today’s capitulation demonstrates a advantage of serve evaluating a drug in an progressing illness environment and provides patients and health caring providers a choice of regulating Zytiga progressing in a march of treatment,” Richard Pazdur, executive of a Office of Oncology Drug Products in a FDA’s Center for Drug Evaluation and Research, pronounced in a statement.
The American Cancer Society estimated that some-more than 28,000 U.S. group will die from prostate cancer in 2012, creation it a second heading means of cancer genocide behind lung cancer.
JJ shares sealed adult 15 cents during $70.60 on a New York Stock Exchange.
(Reporting by Bill Berkrot and Ransdell Pierson; Editing by Gerald E. McCormick, Nick Zieminski and Andrew Hay)
Source: Health Medicine Network