Daurismo is the fourth Pfizer cancer treatment to get FDA approval in two months.
According to the National Cancer Institute, 20,000 people in the United States will be diagnosed with acute myeloid leukemia (AML), and 10,000 people will die this year. AML is a fast-progressing bone marrow cancer that typically affects seniors. Intensive chemotherapy can be effective but often is not suitable for elderly patients.
However, people over 75 with AML now have a new option. Pfizer’s Daurismo (glasdegib) is the seventh new drug approved for AML since 2017 and is specifically intended for patients who are over 75 or who can't take intensive chemotherapy. Once-daily oral Daurismo is approved for use with low-dose chemotherapy.
The approval was based on the results of a phase II clinical trial, which showed a near doubling of the median overall survival for patients receiving the combination compared with those receiving chemotherapy alone.
The approval of Daurismo follows recent FDA approvals for Pfizer’s Lorbrena (lorlatinib), Vizimpro (dacomitinib) and Talzenna (talazoparib). The first two are treatments for certain mutated forms of non-small cell lung cancer, while the latter is for treatment of BRCA-mutated HER2-negative locally advanced or metastatic breast cancer.