New MHRA approval for venetoclax in newly-diagnosed AML

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved AbbVie’s (NYSE: ABBV) Venclyxto (venetoclax) in combination with a hypomethylating agent for the treatment of newly-diagnosed adults with acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy.

The approval applies to Great Britain [England, Scotland and Wales] and follows recent approval by the European Commission (EC) which applies to Northern Ireland in addition to all 27 European Union member states, Iceland, Liechtenstein and Norway.

“AML is an incredibly aggressive form of blood cancer, and patients who are diagnosed with this disease often cannot tolerate intensive chemotherapy due to advanced age and coexisting conditions” said Belinda Byrne, medical director, AbbVie UK, adding: “Regulatory approval of venetoclax, is an important step forward in raising the standard of care for these patients, offering the potential to achieve remission with a manageable safety profile.”