Calquence, also known as acalabrutinib, received U.S. Food and Drug Administration (FDA) approval for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy [1]. This approval was granted on January 25, 2019 [1].
When Was Calquence First Approved?
The initial FDA approval for Calquence occurred on January 25, 2019, for adult patients with relapsed or refractory mantle cell lymphoma [1]. Subsequently, on November 11, 2020, the FDA expanded its approval to include adult patients with previously untreated mantle cell lymphoma [2].
What Type of Cancer Does Calquence Treat?
Calquence is indicated for certain types of non-Hodgkin lymphoma, specifically mantle cell lymphoma (MCL) [1][2]. It is used in both previously treated and untreated adult patients with this condition.
How Does Calquence Work?
Calquence is a Bruton's tyrosine kinase (BTK) inhibitor [1]. It works by blocking the activity of BTK, a protein crucial for the survival and proliferation of certain cancer cells, including those in MCL [1]. By inhibiting BTK, Calquence helps to control or eliminate these cancer cells.
What Are the Common Side Effects of Calquence?
Common side effects reported with Calquence include diarrhea, fatigue, headache, muscle pain, and bruising [1]. More serious side effects can include infections, bleeding events, and heart rhythm problems [1]. Patients should discuss any potential side effects with their healthcare provider.
What is the FDA Approval Status for Calquence for Other Indications?
Beyond mantle cell lymphoma, Calquence also received FDA approval on June 1, 2021, for adult patients with previously treated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) [3]. This expanded its use to include these common B-cell malignancies.
Where Can I Find Information on Calquence Patents?
Information regarding patents for Calquence and its active ingredient, acalabrutinib, can be found through resources like DrugPatentWatch.com [4]. Patent expiration dates are crucial for understanding when generic versions of a drug might become available.