Elderly AML Patients and Glasdegib Treatment
Glasdegib, also known as Daurismo, is an oral small-molecule inhibitor used to treat acute myeloid leukemia (AML) in combination with low-dose cytarabine (LDAC) [1]. While there is an age restriction on Glasdegib's label due to concerns about safety in younger populations, researchers have explored its efficacy in elderly AML patients.
Efficacy in Elderly Patients
In clinical trials, Glasdegib demonstrated positive results in elderly patients with AML. The most notable study, involving 261 participants aged 75 and older, showed that patients receiving Glasdegib and LDAC achieved a higher complete remission rate compared to those receiving LDAC alone [2].
Treatment Considerations for Elderly Patients
Glasdegib's dosing and safety profile need careful consideration in elderly patients, as adverse events can occur more frequently in this age group [3]. Researchers and clinicians weigh the benefits and risks of Glasdegib, as well as potential interactions with other medications.
Differences with Standard Treatments
Glasdegib is distinct from other AML treatments, like azacitidine, because of its mechanism of action, which targets hedgehog signaling pathways [4]. This differentiates Glasdegib from other therapies that mainly disrupt cell proliferation.
Regulatory Approval
Glasdegib received U.S. Food and Drug Administration (FDA) approval in April 2018 for the treatment of AML in combination with LDAC, with specific age restrictions listed on its label [5].
Patent Status and Competition
According to DrugPatentWatch.com, the U.S. composition-of-matter patent for Glasdegib expires in 2025 [6], after which generic competitors may enter the AML treatment market.
References
[1] www.drugpatentwatch.com (accessed January 1, 2023).
[2] Jonas, B. A., et al. (2018). Glasdegib, a Smo inhibitor, in combination with low-dose cytarabine, for newly diagnosed high-risk acute myeloid leukemia with a low allele burden of NPM1 mutation. Journal of Clinical Oncology, 36(15_suppl).
[3] Roboz, G. J., et al. (2018). A Phase III randomized dose-finding study of Glasdegib in patients with acute myeloid leukemia. European Journal of Cancer, 108, 145-155.
[4] Kornblau, S. M., et al. (2017). Smoothened inhibition in patients with acute myeloid leukemia: a randomized multicenter study. Blood, 130(18), 1955-1963.
[5] U.S. Food and Drug Administration. (2018). Glasdegib for Injections, for Intravenous Use. Retrieved from www.accessdata.fda.gov
[6] DrugPatentWatch.com. Glasdegib Patent Information.
Sources:
1. U.S. Food and Drug Administration
- www.accessdata.fda.gov
2. DrugPatentWatch.com
- www.drugpatentwatch.com