Today, the U.S. FDA announced approval for the launch of Pfizer's glasdegib, a combination of low-dose cytarabine (LDAC) chemotherapy for newly diagnosed acute myelogenous leukemia (AML) over 75 years of age, or acute myelogenous leukemia (AML) that cannot be treated with intensive chemotherapy due to chronic health problems and diseases. Patients. It is worth mentioning that this is Pfizer's fourth new
anti-cancer drug approved in just two months!
AML is a rapidly progressing blood and bone marrow cancer. Because of uncontrolled proliferation and accumulation of malignant white blood cells, they are not only dysfunctional, but also affect the formation of normal blood cells. According to the National Cancer Institute (NCI), about 19 520 patients were diagnosed with AML in 2018, and about 10 670 died as a result. The standard treatment for AML is high-intensity chemotherapy, but nearly half of AML patients cannot receive high-intensity chemotherapy due to complications and chemotherapy-related toxicity.
Daurismo is an oral Hedgehog signaling pathway inhibitor developed by Pfizer. It is the first edgehog signaling pathway inhibitor approved by FDA to treat AML. Abnormal activation of the Hedgehog signaling pathway in adults is thought to contribute to the development and survival of cancer stem cells. Pre-clinical studies have shown that disruption of this signaling pathway can impair the development and survival of cancer stem cells. Daurismo has also been awarded the FDA's Orphan Drug Qualification and Priority Assessment Qualification.
This approval is based on Daurismo's performance in a key international randomized phase 2 clinical trial called BRIGHT 1003. In this trial, 115 newly diagnosed AML patients were treated with combination therapy of Daurismo and LDAC or single-drug therapy of LDAC. The results showed that the median overall survival time of patients receiving Daurismo and LDAC combination therapy was 8.3 months (95% CI: 4.4, 12.2), significantly higher than that of patients receiving LDAC alone (95% CI: 1.9, 5.7). The results showed that combination therapy reduced the risk of death by 54% (HR: 0.46, 95% CI: 0.30, 0.71, unilateral P = 0.0002).
"As Pfizer's second approved drug for AML patients in the past 14 months, Daurismo once again demonstrates our commitment to bring innovative drugs to the most difficult cancer patients," said Andy Schmeltz, Pfizer's global president of oncology. "We are happy to be able to offer this to patients who cannot receive intensive chemotherapy. Selection of new oral drugs. Combined with low-dose chemotherapy, it can improve their survival chances.
