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FDA Approves Roche (Genentech) Skin Cancer Drug–Zelboraf

1 Mins read

Cancer drugs certainly are not cheap and for a year, this one is right up there with Provenge in cost with over 100k if it was prescribed for a year.  The diagnosis part of $150 is the easy financial part of this.  In the clinical trials though it was noted that some patients become resistant to the drug.  The approval came earlier than anticipated from the FDA based on the strong clinical data.  BD 

Cancer drugs certainly are not cheap and for a year, this one is right up there with Provenge in cost with over 100k if it was prescribed for a year.  The diagnosis part of $150 is the easy financial part of this.  In the clinical trials though it was noted that some patients become resistant to the drug.  The approval came earlier than anticipated from the FDA based on the strong clinical data.  BD 

U.S. drug regulators approved a targeted skin cancer drug from Roche Holding, offering new hope for patients with the deadliest form of imagecancer after years of few options.

The U.S. Food and Drug Administration was two months ahead of schedule in approving the drug, under the brand name Zelboraf, along with a companion diagnostic test that identifies which patients have a specific genetic mutation that means they will benefit from the treatment.

Zelboraf was developed in partnership with Daiichi Sankyo and is the second drug to be approved for melanoma this year, after Yervoy from Bristol-Myers Squibb

Roche said Zelboraf would cost about $56,400 for a six-month course of treatment in the United States. Bristol’s Yervoy costs $120,000 for a course of treatment. The diagnostic test will cost around $150, according to Paul Brown, president of Roche Diagnostics.

Side effects from Zelboraf include rash, slight hair loss, extreme photosensitivity and joint pain. Roche filed for U.S. approval of the drug in April and the FDA had to make a decision by Oct. 28. Reuters reported on Aug. 10 that an early nod was likely.

http://www.cnbc.com/id/44178560?__source=RSS*tag*&par=RSS

 

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