European Commission approves Daurisma (glasdegib) for certain adult patients with newly diagnosed acute myeloid leukaemia

Pfizer

30 June 2020 - Pfizer today announced that the European Commission approved Daurisma (glasdegib), a Hedgehog pathway inhibitor, in combination with low-dose cytarabine for the treatment of newly diagnosed (de novo or secondary) acute myeloid leukaemia in adult patients who are not candidates for standard chemotherapy. 

The approval follows the medicine’s positive opinion from the CHMP of the EMA earlier this year, as well as the medicine’s approval by the U.S. FDA in November 2018.

The European Commission’s approval of Daurismo is based on results from the Phase 2 BRIGHT 1003 trial, which showed Daurismo nearly doubled median overall survival compared to low-dose cytarabine alone (8.3 months vs. 4.3 months, HR 0.463, 95% CI [0.299,0.717]) in patients with previously untreated (de novo or secondary) acute myeloid leukaemia who were not eligible for intensive chemotherapy.

Read Pfizer press release

Michael Wonder

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Michael Wonder

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Cancer , Outcome , Medicine , Europe