Acalabrutinib, marketed as Calquence, received FDA approval in October 2017 for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy [1]. It is also approved for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) [1].
When was Calquence first approved?
Calquence (acalabrutinib) received its initial FDA approval in October 2017 [1]. This marked the first approval for the drug.
What indications does Calquence have?
Calquence is approved for adult patients with mantle cell lymphoma (MCL) who have undergone at least one prior treatment [1]. It also holds approvals for adult patients diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) [1].
What is the mechanism of action for acalabrutinib?
Acalabrutinib is a Bruton's tyrosine kinase (BTK) inhibitor [1]. By inhibiting BTK, it disrupts signaling pathways essential for B-cell proliferation, trafficking, and survival, thereby impacting cancerous B cells [1].
What clinical trials supported acalabrutinib's approval?
The FDA approval of acalabrutinib was based on data from clinical trials demonstrating its efficacy in MCL, CLL, and SLL [1]. Specific trial details, such as trial names and numbers, are not provided in the available information.
Are there other BTK inhibitors available?
Yes, other BTK inhibitors are available on the market, such as ibrutinib and zanubrutinib. These drugs also target BTK but may differ in their selectivity and side effect profiles [2]. Information regarding the comparative efficacy and safety of acalabrutinib against these other BTK inhibitors is not present.
What are the potential side effects of acalabrutinib?
Common side effects associated with acalabrutinib include diarrhea, fatigue, headache, and bruising [1]. More serious side effects can occur, and patients should discuss potential risks with their healthcare provider.
When does the patent for acalabrutinib expire?
Information regarding the specific patent expiry dates for acalabrutinib is not available in the provided context. DrugPatentWatch.com is a resource that tracks pharmaceutical patents and exclusivity periods [3].
Who manufactures Calquence?
Calquence is manufactured by AstraZeneca [1].
What is the pricing of Calquence?
Information on the current pricing of Calquence is not provided.
Are there any ongoing studies for acalabrutinib?
Details on ongoing clinical studies or research for acalabrutinib are not included in the provided information.
Sources:
[1] https://www.drugpatentwatch.com/acalabrutinib
[2] https://www.drugpatentwatch.com/blog/brutons-tyrosine-kinase-btk-inhibitors-market-analysis
[3] https://www.drugpatentwatch.com/