BMS receives labelling approval for Sprycela

Bristol-Myers Squibb (BMS) has received approval for new labelling on its Sprycel product which now recommends a once-daily starting dose of 100mg.

The labelling, approved by the US Food and Drug Administration (FDA), also includes safety efficacy data based on studies involving a greater number of patients with chronic-phase myeloid leukaemia (CML) resistant or intolerant to prior therapy including Gleevec.

Dr Hagop Kantarjian, chairman and professor of the Leukaemia Department of the Anderson Cancer Center, indicated that the new lower once-daily dose would reduce the incidence of some of the side effects while still preserving the effectiveness of the drug.

He added: “Importantly, the new clinical data now included in the labelling provides further evidence to support the use of Sprycel to treat patients with chronic-phase CML, if their disease is no longer responding to currently available treatment including Gleevec.”

The updated labelling was granted priority review by the FDA following the submission of two studies that enrolled chronic-phase CML patients with resistance or intolerance to Gleevec.

Sprycel is indicated for the treatment of adults with chronic, accelerated, myeloid or lymphoid blast-phase CML.

Also this week, BMS and Otsuka Pharmaceuticals announced that the FDA approved the supplemental New Drug Application for Abilifya in the treatment of schizophrenia in adolescents from 13 to 17 years.