MHRA approves venetoclax as acute myeloid leukemia treatment

pharmafile | June 8, 2021 | News story | Manufacturing and Production EC, EU, MHRA, leukemia 

The MHRA has announced its approval for AbbVie’s venetoclax, in combination with a hypomethylating agent, for the treatment of newly diagnosed adults with acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.

The announcement from the MHRA follows the recent approval from the EC, and is the third extension of indications for the B-cell lymphoma 2 (BCL-2) inhibitor.

BCL-2 is a protein that prevents cancer cells from undergoing apoptosis, the process that normally leads to natural cell death or the self-destruction of cancer cells.

Belinda Byrne, Medical Director of AbbVie UK, said: “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.

“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.”

The MHRA’s approval is based upon data from the Phase III Viale-A study and the Phase Ib open-label, non-randomised, multicentre M14-358 clinical trials. The Viale-A trial demonstrated patients who received venetoclax in combination with azacitidine showed a statistically significantly greater median overall survival than patients receiving azacitidine alone.

The Phase Ib M14-358 trial, evaluating venetoclax in combination with hypomethylating agents, azacitidine or decitabine, exhibited an overall safety profile that was generally consistent with the known safety profiles of venetoclax combined with azacitidine or the two medications alone.

Zack Pemberton-Whiteley, Chief Executive of Leukaemia Care, said: “The MHRA approval of venetoclax combination therapy offers a new option for people facing what is often a devastating acute myeloid leukemia diagnosis.

“This approval represents an important advancement for the treatment of AML and offers an option for those who are ineligible for intensive chemotherapy.”

Kat Jenkins

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