Pfizer Gets First Regulatory Nod For Besponsa

Pfizer's acute lymphocytic leukemia therapy Besponsa has received a positive recommendation in Europe, which should lead to the drug's first approval worldwide and will add to the high expectations for its regulatory outcome in the US later this year.

pills — Pfizer gets EU Green Light For Besponsa, US Is Next • Source: Shutterstock

Pfizer Inc.'s Besponsa (inotuzumab ozogamicin), an orphan drug for acute lymphocytic leukemia, has been given the green light in Europe, spelling good news for the drug's impending US regulatory decision. Once the recommendation is accepted by the European Commission it will represent the first regulatory approval for Besponda worldwide.

In its April round of decisions, the European Medicines Agency's scientific committee, the CHMP, granted Pfizer's drug a positive opinion...