The US regulator approved Genentech’s Supplemental New Drug Applications for Venclexta plus azacitidine under its RTOR and Project Orbis initiative
Genentech headquarters in South San Francisco. (Credit: Coolcaesar/Wikipedia)
Genentech, a pharmaceutical company of the Roche, has secured the US Food and Drug Administration (FDA) approval of Venclexta (venetoclax) plus azacitidine to treat a type of acute myeloid leukaemia (AML).
The US FDA has approved Venclexta in combination with azacitidine, also called low-dose cytarabine (LDAC), to treat newly diagnosed AML in adults aged 75 years or above, or with comorbidities that prevent the use of intensive induction chemotherapy.
Venclexta is a targeted /therapeutic designed to selectively inhibit the B-cell lymphoma-2 (BCL-2) protein, which prevents cancer cells from dying or self-destructing (apoptosis).
The drug is being co-developed by AbbVie and Genentech. Both companies will jointly commercialise the Venclexta in the US and AbbVie will commercialise outside the US.
Genentech chief medical officer and global product development head Levi Garraway “Today’s full approval is supported by the significant results that showed that Venclexta in combination with azacitidine extended overall survival for people with newly diagnosed acute myeloid leukaemia who cannot tolerate intensive induction chemotherapy.
“We are very pleased that this application was reviewed under the FDA’s Real-Time Oncology Review pilot and Project Orbis initiative, helping to bring this treatment option more rapidly to patients in the United States and other countries.”
The company said that the full approval for Venclexta is the recent development over the previous provisional approval under the FDA’s accelerated approval programme, granted in November 2018.
Venclexta has received five FDA Breakthrough Therapy Designations, of which two are indicated for people with previously untreated AML, and ineligible for intensive chemotherapy.
Data from VIALE-A and VIALE-C clinical trials supported the FDA approval of Venclexta
The US regulatory agency has approved the drug combination based on the results from two Phase 3 studies, including VIALE-A and VIALE-C.
VIALE-A is a Phase 3, randomised, double-blind, placebo-controlled multicentre study evaluating the efficacy and safety of Venclexta plus azacitidine, compared to placebo plus azacitidine.
The study enrolled 431 subjects suffering from previously untreated acute myeloid leukaemia, and who are not eligible to receive intensive chemotherapy, and has met its primary and key secondary endpoints.
VIALE-C is a Phase 3 randomised, double-blind, placebo-controlled multicentre study evaluating the efficacy and safety of Venclexta (venetoclax) plus LDAC, compared to placebo with LDAC.
The trial enrolled 211 subjects, suffering from previously untreated acute myeloid leukaemia, who are not eligible to receive intensive chemotherapy.
Results from the study showed that Venclexta plus azacitidine reduced the risk of death (overall survival (OS)) and increased the rate of complete remission (CR) compared to azacitidine alone.
Low white blood cell count with fever, pneumonia, blood infection and bleeding are the most frequent serious adverse reactions reported in VIALE-A trial, while pneumonia, low white blood cell count with fever and blood infection are observed in VIALE-C trial.
Furthermore, the FDA has approved the company’s Supplemental New Drug Applications under its Real-Time Oncology Review pilot program (RTOR) and Project Orbis initiative