AbbVie Granted MHRA Approval for VENCLYXTO®▼ (venetoclax) as a Combination Treatment for Adults Newly Diagnosed with Acute Myeloid Leukaemia Who Are Ineligible for Intensive Chemotherapy

AbbVie Granted MHRA Approval for VENCLYXTO®▼ (venetoclax) as a Combination Treatment for Adults Newly Diagnosed with Acute Myeloid Leukaemia Who Are Ineligible for Intensive Chemotherapy

–        VENCLYXTO® (venetoclax) in combination with a hypomethylating agent is approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy[i]

–        Approval is based on data from AbbVie’s clinical trial programme for venetoclax, including the Phase 3 VIALE-A trial, which showed patients treated with venetoclax in combination with azacitidine demonstrated improvements in overall survival versus patients treated with placebo in combination with azacitidine[ii]

–        Approval is also based on results of the Phase 1b M14-358 trial which showed patients treated with venetoclax in combination with azacitidine or decitabine achieved high remission rates[iii]

MAIDENHEAD, UK, June 7, 2021 – AbbVie today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has approved 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.¹ 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 EU 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. “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.”

This is the third extension of indications for venetoclax, a first-in-class 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.¹  

This most recent approval is based on results from the Phase 3 double-blind, placebo-controlled VIALE-A (M15-656) and the Phase 1b open-label, non-randomised, multicentre M14-358 clinical trials. The VIALE-A trial demonstrated patients who received venetoclax in combination with azacitidine (n= 286) showed a statistically significantly greater median overall survival (OS) than patients receiving azacitidine alone (n=144) (14.7 vs. 9.6 months) (HR=0.66; p<0.001).² The Phase 1b 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.³

In the VIALE-A trial, the most frequently reported serious adverse events (AEs) (≥5%) in the venetoclax plus azacitidine arm, and placebo plus azacitidine arm, were febrile neutropenia, pneumonia, sepsis, and haemorrhage.¹ In the M14-358 trial, the most frequently reported serious AEs (≥5%) in patients receiving venetoclax in combination with decitabine were febrile neutropenia, pneumonia, bacteraemia and sepsis.¹

“The MHRA approval of venetoclax combination therapy offers a new option for people facing what is often a devastating acute myeloid leukemia diagnosis,” said Zack Pemberton-Whiteley, Chief Executive of Leukaemia Care. “This approval represents an important advancement for the treatment of AML and offers an option for those who are ineligible for intensive chemotherapy.”

Venetoclax is being developed by AbbVie and Roche. It is commercialised by AbbVie outside of the U.S. and jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the U.S.