Roche seeks FDA approval of Venclexta for certain patients with treatment-naïve AML

Roche on Thursday announced that it has submitted a filing with the FDA seeking to expand the indication for Venclexta (venetoclax) to include combination use with a hypomethylating agent or low-dose cytarabine for patients with previously untreated acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy. Roche chief medical officer Sandra Horning remarked "we look forward to working closely with the FDA to bring this potential option to patients with this very difficult-to-treat blood cancer as soon as possible."  

According to Roche, the submission was supported by efficacy and safety data from two Phase Ib/II studies. In the Phase Ib M14-358 study, Venclexta administered at a dose of 400 mg in combination with azacitidine or decitabine was linked to a complete response rate of 73 percent, with a median overall survival (OS) across all Venclexta dose groups  after more than one year of follow-up of 17.5 months. Meanwhile, in the Phase Ib/II M14-387 trial, Venclexta at a dose of 600 mg plus low-dose cytarabine was associated with a complete response/complete response with incomplete haematologic recovery rate of 62 percent , while the median OS was 11.4 months. 

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Venclexta was granted breakthrough therapy designation by the FDA last year for combination use with low-dose cytarabine in certain patients with AML, while the drug was separately awarded breakthrough therapy status for the treatment of AML in combination with hypomethylating agents. The therapy is jointly marketed by Roche's Genentech unit and AbbVie within the US and by the latter company in other markets.

Venclexta was previously awarded accelerated approval by the FDA for the treatment of certain patients with chronic lymphocytic leukaemia (CLL). The indication was later expanded to include use together with Roche and Biogen's Rituxan (rituximab) in previously treated patients with CLL or small lymphocytic lymphoma.

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