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Re: biomaven0 post# 143225

Thursday, 06/14/2012 9:53:11 PM

Thursday, June 14, 2012 9:53:11 PM

Post# of 257580

The safety hurdles [for cancer drugs] are much lower than in virtually any other space, and reimbursement is also pretty clear.

Well, UK’s NICE just rejected Zelboraf:

http://in.reuters.com/article/2012/06/14/us-roche-britain-idINBRE85D1RJ20120614

The National Institute for Health and Clinical Excellence said on Friday that while Zelboraf was effective for melanoma patients with a particular genetic mutation, its longer-term effect on survival was uncertain.

NICE said that, as a result, it could not recommend the drug as a cost-effective treatment for the deadliest form of skin cancer within the state-run National Health Service (NHS), even after an undisclosed price discount offered by Roche.

This sentence should worry other cancer-drug companies:

NICE said the longer-term survival benefits from using Zelboraf were uncertain because many patients in a key trial switched treatment as their disease progressed.

In other words, Zelboraf is being penalized for having its pivotal trial halted early due to strong efficacy.

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