Efficacy

Efficacy of Daurismo (Glasdegib) in Leukemia

Daurismo, known by its generic name glasdegib, is a medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are 75 years of age or older, or who have comorbidities that preclude the use of intensive induction chemotherapy. Glasdegib is used in combination with low-dose cytarabine (LDAC), a type of chemotherapy. Clinical trials have demonstrated that patients treated with glasdegib in combination with LDAC had a median overall survival of 8.3 months compared to 4.3 months for patients treated with LDAC alone, indicating a significant improvement in survival outcomes for this patient population.

The efficacy of Daurismo is attributed to its mechanism of action as a hedgehog pathway inhibitor. This pathway is thought to be involved in the development of cancer stem cells, and its inhibition can potentially reduce the number of these malignant cells, thereby slowing down the progression of the disease. The approval of glasdegib was based on the results of a multicenter, randomized, open-label clinical trial, which underscored its benefit in extending overall survival in patients with AML who are not candidates for standard chemotherapy.

Efficacy of Vanflyta (Quizartinib) in Leukemia

Vanflyta, with the generic name quizartinib, is an oral tyrosine kinase inhibitor specifically targeting FLT3 (FMS-like tyrosine kinase 3), which is mutated in a significant proportion of AML patients. While quizartinib has shown promise in clinical trials, it is important to note that as of my knowledge cutoff in 2023, it has not received approval by the FDA for the treatment of AML. However, it has been granted approval in Japan for the treatment of relapsed or refractory FLT3-ITD AML, a particularly aggressive form of the disease.

In clinical trials, quizartinib has demonstrated efficacy in prolonging overall survival in patients with relapsed or refractory FLT3-ITD AML. The pivotal Phase 3 study, known as the QuANTUM-R trial, showed that quizartinib monotherapy resulted in a median overall survival of 6.2 months compared to 4.7 months for chemotherapy. The results suggest that quizartinib could provide a meaningful survival benefit for patients with this challenging form of leukemia. However, the clinical development and regulatory status of quizartinib may continue to evolve, and it is important to consult the latest medical literature and regulatory updates for the most current information regarding its efficacy and approval status.