NICE issues negative draft opinion on Vidaza in AML

8 April 2016

US biotech firm Celgene (Nasdaq: CELG) expressed disappointment with a draft decision issued today by the drug cost-effectiveness watchdog for England, the National Institute for Health and Care Excellence (NICE).

The draft does not recommend the company’s Vidaza) azacitidine as an option to treat acute myeloid leukemia (AML ) in patients aged 65 years or older with more than 30% bone marrow blasts (according to the WHO classification) who are not eligible for hematopoietic stem cell transplantation (HSCT).

Azacitidine has the potential to provide a vital life-line to eligible people with AML; in a Phase III clinical trial of 488 patients it demonstrated a median improvement in survival of 3.8 months (10.4 versus 6.5 months, HR=0.85 [95% CI 0.69, 1.03] p=0.1009) compared with conventional care regimens, stated Celgene. The most common serious adverse reactions (≥ 10%) noted from AZA-AML-001 within the azacitidine treatment arm included febrile neutropenia (25.0%), pneumonia (20.3%), and pyrexia (10.6%).

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