Calquence, a medication used to treat certain types of non-Hodgkin lymphoma, received FDA approval on October 10, 2018 [1].
What is Calquence approved to treat?
The initial FDA approval for Calquence (acalabrutinib) was for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy [1]. Subsequently, its use was expanded. In June 2019, the FDA approved Calquence for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least one prior therapy [2]. In March 2022, a new indication was approved for the treatment of adult patients with CLL or SLL without prior therapy [3].
How does Calquence work?
Calquence is a Bruton's tyrosine kinase (BTK) inhibitor [1]. BTK is a protein that plays a crucial role in the development and survival of certain white blood cells, including malignant B-cells [4]. By inhibiting BTK, Calquence disrupts the signaling pathways that allow these cancer cells to grow and multiply [4].
When did Calquence receive its first FDA approval?
Calquence was first approved by the U.S. Food and Drug Administration (FDA) on October 10, 2018 [1].
Has Calquence received approval for use in patients who haven't had prior treatment?
Yes, Calquence received approval for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have not received prior therapy in March 2022 [3]. Prior to this, it was approved for patients who had received at least one prior therapy for these conditions [2].
What is the patent status for Calquence?
Information regarding the specific patent expiry dates for Calquence can be found on DrugPatentWatch.com [5]. Patents protect drugs from generic competition for a set period, and understanding this timeline is crucial for market dynamics and the potential introduction of biosimilars or generics.
Who manufactures Calquence?
Calquence is manufactured by AstraZeneca [1].