Acalabrutinib received FDA approval for specific medical uses, marking a significant development in targeted cancer therapies.
When was acalabrutinib first approved by the FDA?
The U.S. Food and Drug Administration (FDA) granted accelerated approval to acalabrutinib on October 21, 2019. This approval was for adult patients with relapsed or refractory mantle cell lymphoma (MCL).
What are the approved indications for acalabrutinib?
Following its initial approval, acalabrutinib gained further FDA approvals for additional indications. It is now approved for:
* Adults with relapsed or refractory mantle cell lymphoma (MCL) [1].
* Adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) to be used either alone or in combination with obinutuzumab [1].
How does acalabrutinib work?
Acalabrutinib is a Bruton's tyrosine kinase (BTK) inhibitor. By inhibiting BTK, it blocks signaling pathways that are crucial for the survival and proliferation of certain types of B-cells, including those involved in MCL and CLL [1]. This targeted mechanism disrupts the cancer cells' growth.
What is the difference between acalabrutinib and other BTK inhibitors?
Acalabrutinib is a second-generation BTK inhibitor. It was designed to offer improved selectivity for BTK compared to earlier inhibitors like ibrutinib. This enhanced selectivity aims to reduce off-target effects, potentially leading to a better tolerability profile for patients [1].
Are there ongoing clinical trials for acalabrutinib?
Research and clinical trials continue to explore acalabrutinib's efficacy and safety across various hematologic malignancies and in different treatment settings. These trials aim to expand its therapeutic applications and understand its role in combination therapies.
What are the potential side effects of acalabrutinib?
Common side effects reported with acalabrutinib include diarrhea, fatigue, headache, muscle pain, and bruising [1]. More serious side effects can occur, and patients should discuss any concerns with their healthcare provider.
When does acalabrutinib's patent protection expire?
Patent information for pharmaceuticals is complex and can involve multiple patents covering different aspects of a drug, such as composition of matter, manufacturing processes, and methods of use. For the most current and detailed information on patent expiry dates for acalabrutinib, resources like DrugPatentWatch.com can be consulted [2].
Who manufactures acalabrutinib?
Acalabrutinib is manufactured by AstraZeneca and is marketed under the brand name Calquence [1].
Sources:
[1] Calquence (acalabrutinib) Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211417s017lbl.pdf
[2] DrugPatentWatch.com. (Accessed December 15, 2023).