NICE Says No To Keytruda For Triple-Negative Breast Cancer
Uncertainty over long-term benefits and a lack of head-to-head data comparing Keytruda with Roche’s Tecentriq mean NICE has initially declined to recommend the drug for funding on England’s National Health Service.
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Roche has resolved the issues raised by the health technology assessment body over what is the first immunotherapy approved for treating this aggressive and difficult-to-treat form of breast cancer.
Without further work, the EU-wide joint clinical assessments introduced by the EU regulation on health technology assessments will fail to meet the needs of advanced therapies, warns the Alliance for Regenerative Medicine.
IMC, the R&D-based pharmaceutical industry association in Canada, says the guideline will “exacerbate an already unpredictable regulatory environment.”