CHMP approve Bristol-Myers Squibb's Sprycel for paediatric patients with Ph+ ALL

New Jersey-based firm Bristol -Myers Squibb today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the expanded approval of Sprycel (dasatinib), in combination with chemotherapy for the treatment of paediatric patients (Ph+) acute lymphoblastic leukemia (ALL).

The powder form of Sprycel, which allows patients with an inability to swallow tablets to suspnd the medicines in water, was first approved by the European Commission in July 2018.

"We are pleased with today’s CHMP recommendation for Sprycel in pediatric patients with Ph+ ALL, and look forward to the possibility of expanding Sprycel’spediatric indications in the EU to include young patients with this particularly high-risk leukemia," said Fouad Namouni, M.D., head, oncology development, Bristol-Myers Squibb.