SWITZERLAND – Roche’s Venclexta has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with previously untreated intermediate, high- and very high-risk myelodysplastic syndromes (MDS).
This designation was granted based on interim results from the phase 1b M15-531 study investigating Venclexta/Venclyxto plus azacitidine in people with previously untreated, higher-risk MDS.
The approval will become the 38th BTD for Roche’s portfolio of medicines, and the 11th designation for its haematology portfolio.
In the US, Venclexta has been granted six BTDs by the FDA: one for previously untreated chronic lymphocytic leukaemia (CLL), two for relapsed or refractory CLL, two for previously untreated acute myeloid leukaemia (AML), and one for MDS.
Venclexta/Venclyxto is already approved in the US (as Venclexta) for the treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
It also approved in the EU (as Venclyxto) in combination with hypomethylating agents, azacitidine and decitabine, for the treatment of adult patients with newly diagnosed AML who are ineligible for intensive chemotherapy.
Venclexta/Venclyxto is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the US, under the brand name Venclexta, and commercialized by AbbVie outside of the US.
The M15 – 531 study
The M15-531 study is a phase 1 b, open-label, non-randomized, multicenter, dose-finding study evaluating Venclexta in combination with azacitidine in treatment-naïve patients with higher-risk myelodysplastic syndromes (MDS) comprising a dose-escalation portion and a safety expansion portion.
Primary objective of the study was to assess the safety profile and pharmacokinetics and determine the recommended phase II dose and dosing schedule of Venclexta/in combination with azacitidine.
Roche has been developing medicines for people with malignant and non-malignant blood diseases for over 20 years and the company boasts of vast experience and knowledge within this scope of medicine.
The company is continually investing more than ever in an effort to bring innovative treatment options to patients across a wide range of haematologic diseases.
Their portfolio runs deep with numerous approved drugs by the FDA which include, MabThera (rituximab), Gazyva (obinutuzumab), Polivy (polatuzumab vedotin), Venclexta (venetoclax) in collaboration with AbbVie, and Hemlibra (emicizumab).
Roche’s investigational haematology medicine pipeline includes T-cell engaging bispecific antibodies, glofitamab and mosunetuzumab, targeting both CD20 and CD3.
Cevostamab, targeting FcRH5 and CD3; Tecentriq (atezolizumab), a monoclonal antibody designed to bind with PD-L1; and crovalimab, an anti-C5 antibody engineered to optimize complement inhibition.
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