The United States Food and Drug Administration (FDA) announced Wednesday that it has approved Pfizer’s blood cancer treatment Daurismo.
Daurismo (glasdegib) tablets are used in combination with a type of chemotherapy called low-dose cytarabine (LDAC) to treat newly-diagnosed acute myeloid leukemia (AML). Specifically, this combo is used to treat new cases of AML in adults 75 years of age or older. The drug treatment will also benefit other people with chronic health conditions or diseases that make intensive chemotherapy extremely difficult (if not impossible) to tolerate due to its toxicities. Nearly half of adults diagnosed with AML do not receive chemotherapy for these reasons.
AML is a fast-moving blood cancer that begins in the bone marrow. The diagnosis and recovery statistics are striking, as the FDA notes. According to the National Cancer Institute, in 2018, approximately 19,520 people will be diagnosed with AML. Of those patients with AML, approximately 10,670 will die of the disease.
Daruismo comes with a “boxed warning”—the FDA’s strictest, most prominent labeling—that warns taking the drug raises the risk of embryo-fetal death or severe birth defects.
Pfizer has been working on multiple fronts to develop and gain approval for various blood cancer treatments. In 2017, the pharmaceutical giant was awarded FDA approval for Besponsa, which is used to treat a rare, difficult-to-treatment form of leukemia called acute lymphoblastic leukemia (ALL), which kills roughly 1,400 Americans annually.