In a second disappointment from the agency this week, US drugs behemoth Pfizer (NYSE: PFE) Ltd expressed concern that guidance from the UK’s drug watchdog National Institute for Health and Clinical Excellence (NICE) does not recommend its Inlyta (axitinib), a new treatment for patients with advanced renal cell carcinoma (commonly known as kidney cancer) who are no longer receiving clinical benefit from treatment with sunitinib or a cytokine.
This final draft guidance comes just a day after the firm also received a negative preliminary guidance for its lung cancer drug Xalkori (crizotinib; The Pharma Letter March 27).
The NICE Final Appraisal Determination (FAD) recognizes that axitinib is a life-extending, end of life treatment for patients who were previously treated with sunitinib, but does not consider it to be cost effective. Pfizer disagrees with this decision, and is investigating whether or not there are grounds to appeal the recommendation. The NICE does not currently recommend any targeted therapies for advanced kidney cancer following failure of first-line therapy.
Manufacturer provided “indirect” and “simulated” comparisons
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