The approval has been granted for Daurismo, a Hedgehog pathway inhibitor, in combination with low-dose cytarabine (LDAC), a type of chemotherapy, to treat newly diagnosed AML in adult patients who are not candidates for standard chemotherapy.
The approval is said to follow Daurismo’s positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) earlier this year, as well as the medicine’s approval by the US Food and Drug Administration (FDA) in November 2018.
Daurismo’s approval was based on data from the phase 2 BRIGHT 1003 trial, which demonstrated that the medicine nearly doubled median overall survival compared to LDAC alone in patients with previously untreated AML who were not eligible for intensive chemotherapy.
The company randomised 116 patients with previously untreated secondary AML who were not eligible to receive intensive chemotherapy in 2:1 ratio to secure Daurismo plus LDAC or LDAC alone in the phase 2 BRIGHT 1003 trial.
Pfizer oncology international developed markets regional president Masum Hossain said: “The standard of care for people with acute myeloid leukemia is intensive chemotherapy, however, this is not an option for many elderly people and those who have certain health conditions prior to receiving their diagnosis.
“Through the European Commission approval of DAURISMO, we are proud to further deliver on our decades long commitment to people living with blood cancers by offering this new treatment option for certain patients in Europe with acute myeloid leukaemia, who previously had limited treatment options.”
In the US and Canada, Daurismo secured approval in combination with LDAC to treat newly diagnosed AML in adult patients who are 75 years or older or who have comorbidities that preclude use of intensive induction chemotherapy.
Recently, Pfizer and Biopharmaceutical New Technologies (BioNTech) have dosed the first participants of a phase 1/2 trial for their Covid-19 vaccine candidate BNT162 in the US.