Calquense (alcabrutininb) for Waldenstrom’s – pro
There is clinical evidence regarding the effectiveness of this drug, Calquence for this indication, Waldenstrom Macroglobulinemia (WM) as published in the authoritative, peer-reviewed medical and scientific literature. There are many phase II studies suggesting effectiveness. Acalabrutinib is a highly effective treatment for WM with durable responses and limited toxicity. Therefore, the request for Calquence is medically necessary for this patient.
A recent ASCO presentation concluded that: “Whether you’re looking at ibrutinib, acalabrutinib, or zanubrutinib, the level of activity seems to be almost the same. We tend to see an adverse-effect profile that is very, very comparable and really wouldn’t motivate anybody to pick 1 over the other. It may come down ultimately to convenience once a day administration with ibrutinib versus twice a day administration. And also, because of off-target effects, there might be adverse effects that may be present with ibrutinib that you may not see for a particular patient with these newer-generation inhibitors. So if somebody is unable to tolerate ibrutinib because of these ongoing grade 1 or grade 2 toxicities, at least knowing that new BTK inhibitors are present will allow one to be able to consider maybe using 1 of these in lieu of.” (Kahl, B. S. and Treon, S. P., 2019).
Per Owen, R.G. et al. (2019), “This study provides evidence that acalabrutinib is active as single-agent therapy with a manageable safety profile in patients with treatment-naive, or relapse or refractory Waldenström macroglobulinemia.”
Per Castillo JJ1, Treon SP2 (2019), “Current treatment options for symptomatic WM patients include alkylating agents, proteasome inhibitors and anti-CD20 monoclonal antibodies. The approval of the oral Bruton tyrosine kinase (BTK) inhibitor ibrutinib alone and in combination with rituximab has expanded the treatment options for WM patients. The present Perspective would focus on exciting treatment strategies under development for WM patients, such as proteasome inhibitors (e.g., ixazomib), BTK inhibitors (e.g., acalabrutinib, zanubrutinib, vecabrutinib), BCL2 inhibitors (e.g., venetoclax), and anti-CXCR4 antibodies (e.g., ulocuplumab), among others. It is certainly an exciting time for WM therapy development with novel and promising treatment options in the horizon.”
PEER REVIEWED PUBLICATION/LITERATURE:
Owen, R.G. et al. (2019). Acalabrutinib monotherapy in patients with Waldenström macroglobulinemia: a single-arm, multicentre, phase 2 study. DOI:https://doi.org/10.1016/S2352-3026(19)30210-8
Castillo JJ1, Treon SP2 (2019). What is new in the treatment of Waldenstrom macroglobulinemia? Leukemia. 2019 Nov;33(11):2555-2562. doi: 10.1038/s41375-019-0592-8. Epub 2019 Oct 7.
Kahl, B. S. and Treon, S. P. (2019). BTK Inhibitors in Waldenstrom Macroglobulinemia. SCO 2019: https://www.onclive.com/insights/evolving-treatment-btk-inhibitors/btk-inhibitors-in-waldenstrom-macroglobulinemia