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EMA CHMP grants positive opinion for venetoclax in combination with hypomethylating agents for the treatment of patients with newly diagnosed AML
On April 23, 2021, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion for venetoclax in combination with hypomethylating agents for the treatment of newly diagnosed acute myeloid leukaemia (AML) in patients ineligible for intensive chemotherapy.1
Venetoclax is a selective BCL-2 inhibitor already approved by the U.S. Food and Drug Administration (FDA) in combination with azacitidine, decitabine, or low‑dose cytarabine for the treatment of patients with newly diagnosed AML who are ineligible for intensive chemotherapy. Venetoclax is also indicated for the treatment of chronic lymphocytic leukaemia.
The positive CHMP opinion is the third for an extension of indications for venetoclax and it is based on data from the phase III VIALE-A (NCT02993523) and the phase Ib M14-358 (NCT02203773) trials.
The VIALE-A trial evaluated the combination of venetoclax + azacitidine versus placebo + azacitidine in patients with newly diagnosed AML ineligible for intensive chemotherapy. Results from this trial showed a significant improvement of overall survival (14.7 months vs 9.6 months), as well as complete remission and complete remission with incomplete hematologic recovery (CR/CRi) rate (66.4% vs 28.3%), in patients treated with the combination of venetoclax + azacitidine compared with placebo + azacitidine. More details on the trial results can be found here.
The M14-358 trial, evaluating the combination of venetoclax with azacitidine or decitabine in patients with newly diagnosed AML, showed a CR/CRi rate of 71% in patients receiving venetoclax + azacitidine and of 74% in those treated with venetoclax + decitabine. The responses were durable, with a median duration of response of 21.9 months and 15.0 months for venetoclax + azacitidine and venetoclax + decitabine, respectively. More details on the trial results can be found here.
The European Commission’s final decision on venetoclax combination therapy in AML is expected in the first half of 2021.
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