- The Food and Drug Administration has approved Pfizer's Daurismo for patients with acute myeloid leukemia (AML) who are over 75 or who can't take intensive chemotherapy, a particularly hard-to-treat population.
- The approval of once-daily oral Daurismo with low-dose chemotherapy is based on the results of a Phase 2 trial. Data showed the Daurismo combination nearly doubled median overall survival, at 8.3 months, compared with chemotherapy alone, at 4.3 months.
- Approval for Daurismo adds another option for a cancer type that until recently had few treatment choices, and extends a streak of recent OK's Pfizer's secured for its cancer drug portfolio.
AML is a fast-progressing bone marrow cancer that generally affects older adults. This year, the National Cancer Institute estimates nearly 20,000 Americans will be diagnosed with the disease, and more than 10,000 will die.
Intensive chemotherapy has been a standard treatment option, but isn't always suitable for elderly patients or people with other comorbidities.
Daurismo (glasdegib) is the seventh new drug approved for AML since 2017 after years without new medicines.
This run of OKs includes Roche and AbbVie's Venclexta (venetoclax), which received an accelerated approval last week for use with azacitidine, decitabine or low-dose cytarabine in the same population as Daurismo.
The Phase 2 study supporting approval of Daurismo included patients with cardiac disease or mild to moderate kidney disease, who are often excluded from clinical trials according to a statement from Pifzer.
"[M]any adults with AML are unable to have intensive chemotherapy because of its toxicities," said Richard Pazdur, director of the FDA's Oncology Center of Excellence, in a statement. "Today’s approval gives health care providers another tool to use in the treatment of AML patients with various, unique needs."
Daurismo carries a boxed warning for the risk of severe birth defects or fetal death in pregnant women, although women of reproductive age aren't Pfizer's target market for this therapy.
Daurismo is the fourth drug of Pfizer's approved in a roughly two-month span, a notable achievement even if none are projected to be major blockbusters.
Two, Lorbrena (lorlatinib) and Vizimpro (dacomitinib), received approval for certain mutated forms of non-small cell lung cancer. The third, a PARP inhibitor called Talzenna (talazoparib), is OK'd for BRCA-mutated HER2-negative locally advanced or metastatic breast cancer.