Venclyxto-based combination treatments are indicated for adults with newly diagnosed AML, who are not eligible for intensive chemotherapy
Roche’s Venclyxto combinations approved in EU. (Credit: F. Hoffmann-La Roche Ltd.)
Roche has received the European Commission (EC) approval for its Venclyxto (venetoclax) in combination with hypomethylating agents, azacitidine and decitabine, to treat a type of acute myeloid leukaemia (AML).
The EC indicated Venclyxto-based combination treatments for adult patients with newly diagnosed AML, who are not eligible for intensive chemotherapy.
AML is an aggressive form of leukaemia that originates in myeloid cells, the immature forms of blood-forming cells, found in the bone marrow.
Venclyxto is a targeted medicine designed to specifically bind and inhibit the B-cell lymphoma-2 (BCL-2) protein, which prevents apoptosis of cancer cells.
The drug is being jointly developed by AbbVie and Roche, and commercialised by AbbVie and Genentech, a subsidiary of Roche, in the US, and by AbbVie outside of the US.
The US Food and Drug Administration has granted five Breakthrough Therapy Designations for Venclexta, one for previously untreated chronic lymphocytic leukaemia (CLL), two for relapsed or refractory CLL and two for previously untreated AML.
Roche chief medical officer and global product development head Levi Garraway said: “This Venclyxto approval is a critical step in providing new therapeutic options for patients in the EU newly diagnosed with AML who cannot tolerate the side effects of, or are ineligible for, intensive chemotherapy.
“Venclyxto-based combinations continue to show meaningful clinical benefits in AML patients, who would otherwise have a poor prognosis.”
The EC approval is based on the results from two studies, including Phase 3 VIALE-A and Phase 1/2 M14-358 trials, which evaluated Venclyxto-based combination therapies.
In the Phase 3 VIALE-A study, treatment using Venclyxto plus azacitidine showed a significant reduction in the risk of death by 34%, compared to azacitidine alone.
The Venclyxto combination more than doubled the complete responses (CRs), with a CR rate of 37% compared to 18% in the comparator arm.
Also, the Venclyxto plus azacitidine combination resulted in higher rates of composite complete remission at 66% compared to 28% with azacitidine alone.
Results from the M14-358 study showed that patients receiving Venclyxto in combination with decitabine achieved a CR + CRi rate of 74%.
The EC approval will strengthen the potential of Venclyxto-based combinations in offering clinically meaningful benefits across several diseases, including AML, said the company.