Pfizer’s Daurismo becomes first of its kind to secure FDA approval in acute myeloid leukaemia

pharmafile | November 22, 2018 | News story | Research and Development, Sales and Marketing AML, Daurismo, FDA, Pfizer, US, leukaemia 

Pfizer has revealed that the FDA has chosen to approve its Daurismo (glasdegib) for the treatment of newly-diagnosed acute myeloid leukaemia (AML) in over-75s for whom the use of intensive induction chemotherapy is not suitable due to comorbidities. The drug is to be used in combination with low-dose cytarabine (LDAC) chemotherapy.  

The ruling makes the drug the first and only FDA-approved Hedgehog pathway inhibitor for AML, according to the manufacturer. The decision was based on Phase 2 data derived from 115 newly-diagnosed participants, in which Daurismo plus LDAC demonstrated a median overall survival of 8.3 months compared to 4.3 months for LDAC alone, and a 54% reduction in the risk of death.

“The randomised Phase 2 study, which formed the basis for today’s approval, included patients with cardiac disease or mild to moderate kidney disease, who are often excluded from clinical trials,” commented Dr Jorge Cortes, Deputy Chair and Professor of Medicine in the Department of Leukemia, at the University of Texas, MD Anderson Cancer Center. “In the trial, Daurismo plus low-dose chemotherapy reduced the risk of death during the study period by 54% compared to chemotherapy alone. This provides a much-needed treatment for those patients for whom intensive chemotherapy is not an option.”

Pfizer Oncology’s Global President Andy Schmeltz also remarked: “As our second medicine approved in the last 14 months for patients with acute myeloid leukaemia, Daurismo reinforces our commitment to delivering new medicines to patients living with some of the most difficult-to-treat cancers, especially those for which there are limited treatment options available. We are proud to now offer these patients for whom intensive chemotherapy is not an option a new oral medicine, taken in combination with low-dose chemotherapy, that may improve their chances of survival.”

Matt Fellows

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