Pfizer receives FDA approval for its AML drug

22 November 2018

GMP News

Pfizer announced that the U.S. Food and Drug Administration (FDA) approved DAURISMO™ (glasdegib), a once-daily oral medicine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are 75 years or older or who have comorbidities that preclude use of intensive induction chemotherapy.

AML is a rapidly progressing bone marrow cancer with poor survival rates compared to other leukemias. The standard of care for people with AML is intensive chemotherapy; however, for many elderly patients with AML, as well as those who have certain health conditions prior to receiving their diagnosis, intensive treatment is not an option. Historically, a majority of these individuals do not receive treatment and face a poor prognosis.

DAURISMO is taken in combination with low-dose cytarabine (LDAC), a type of chemotherapy. The drug has not been studied in patients with severe renal impairment or moderate-to-severe hepatic impairment.

DAURISMO is the first and only FDA-approved Hedgehog pathway inhibitor for AML. The Hedgehog signaling pathway plays an essential role in embryogenesis, the process by which human embryos are developed. In adults, however, abnormal activation of this pathway is thought to contribute to the development and persistence of cancer stem cells. Preclinical studies have shown that disruption of this pathway can impair the development and survival of these cancer stem cells. DAURISMO is not approved for any indication outside the USA.

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