The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved AbbVie and Roche’s Venclyxto for the treatment of newly diagnosed acute myeloid leukaemia (AML).
The MHRA has cleared Venclyxto (venetoclax) in combination with a hypomethylating agent for the treatment of patients who are ineligible for intensive chemotherapy.
The approval is based on results from the Phase III VIALE-A study as well as the Phase Ib M14-358 clinical trial.
In VIALE-A, patients who received Venclyxto in combination with azacitidine showed a statistically significant greater median overall survival (OS) compared to patients receiving azacitidine alone.
Meanwhile, the M14-358, which evaluated Venclyxto in combination with hypomethylating agents, demonstrated an overall safety profile that was consistent with the known safety profiles of the drug combined with azacitidine or the two medications alone.
“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.
“Regulatory approval of Venclyxto, 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,” she added.
This new approval is the third extension of indications for Venclyxto by the MHRA, a first-in-class B-cell lymphoma inhibitor.