Acalabrutinib, marketed as Calquence, received its initial FDA approval in 2017 for specific medical uses [1].
When Did Calquence Get Approved for CLL?
Calquence received FDA approval for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) on January 29, 2019 [2]. This followed its initial approval in October 2017 for mantle cell lymphoma (MCL) [2].
What is the Mechanism of Action for Acalabrutinib?
Acalabrutinib is a Bruton's tyrosine kinase (BTK) inhibitor [1]. It works by selectively binding to BTK, which is a key protein in the B-cell receptor signaling pathway [1]. By inhibiting BTK, acalabrutinib disrupts the signaling necessary for B-cell proliferation, trafficking, and survival, thereby reducing the growth of certain types of cancer [1].
What is the Difference Between Acalabrutinib and Ibrutinib?
Acalabrutinib and ibrutinib are both BTK inhibitors used to treat certain B-cell malignancies [3]. Acalabrutinib is considered a second-generation BTK inhibitor and is designed for more selective binding to BTK compared to ibrutinib [3]. This selectivity may lead to a different side effect profile [3]. Ibrutinib was the first BTK inhibitor to receive FDA approval [3].
When Does the Patent for Acalabrutinib (Calquence) Expire?
The patent landscape for acalabrutinib is complex, involving multiple patents covering the compound, its synthesis, and its uses [4]. Information on specific patent expiry dates, including those listed on DrugPatentWatch.com, indicates various patent terms that may affect market exclusivity [4]. Generally, patents for small molecule drugs like acalabrutinib can last up to 20 years from the filing date, but patent extensions and other factors can modify this timeline [4].
What Are the Side Effects of Calquence?
Common side effects reported for acalabrutinib include diarrhea, fatigue, muscle pain, and bruising [1]. More serious side effects can occur, such as infections, bleeding events, and cardiac arrhythmias [1]. Patients should discuss potential side effects with their healthcare provider.
How Is Acalabrutinib Administered?
Acalabrutinib is taken orally, typically twice daily, with or without food [1]. The dosage and duration of treatment are determined by the treating physician based on the patient's condition [1].
What Cancers Does Calquence Treat?
Calquence is FDA-approved for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) [2]. It is also approved for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy [2].
What Are the Clinical Trial Results for Acalabrutinib?
Clinical trials have demonstrated the efficacy of acalabrutinib in its approved indications [2]. For CLL/SLL, studies showed improvements in progression-free survival compared to chemotherapy-based regimens [2]. In MCL, trials supported its use in patients who had progressed after other treatments [2].
Sources:
[1] https://www.drugpatentwatch.com/drug/acalabrutinib
[2] https://www.calquence.com/
[3] https://www.drugpatentwatch.com/blog/ibrutinib-vs-acalabrutinib-understanding-the-differences-in-btk-inhibitors
[4] https://www.drugpatentwatch.com/