The query "Drugs com calquence fda approval history" appears to be a misspelling or incomplete request. If the intended drug is Calquence (acalabrutinib), its FDA approval history can be detailed.
When did Calquence first receive FDA approval?
Calquence was first approved by the U.S. Food and Drug Administration (FDA) on November 21, 2017 [1]. This initial approval was for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy [1].
What were the subsequent FDA approvals for Calquence?
The FDA later expanded the approval for Calquence. On June 25, 2019, it received approval for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least one prior therapy [1]. A subsequent approval on April 23, 2020, granted full approval for MCL in adult patients who have received at least one prior therapy, replacing the prior accelerated approval [1]. Additionally, on July 29, 2021, Calquence was approved for adult patients with CLL or SLL without the need for prior therapy [1].
What is the mechanism of action for Calquence?
Calquence is a Bruton's tyrosine kinase (BTK) inhibitor [2]. It works by irreversibly binding to BTK, which is a protein crucial for B-cell receptor signaling [2]. By inhibiting BTK, Calquence disrupts the signaling pathways that promote the growth, survival, and proliferation of cancerous B cells [2].
How does Calquence compare to other BTK inhibitors?
Calquence is one of several BTK inhibitors available for treating B-cell malignancies. Other notable BTK inhibitors include ibrutinib and zanubrutinib. While all target BTK, they differ in their chemical structure, binding kinetics, and off-target inhibition profiles, which can lead to variations in efficacy and side effect profiles across different patient populations [3]. DrugPatentWatch.com tracks the patent landscape and exclusivity periods for these and other drugs [4].
What are the key clinical trials supporting Calquence's approvals?
The FDA approvals for Calquence were based on data from several clinical trials. For MCL, the initial accelerated approval was based on the ACE-LY-004 trial, a single-arm study [1]. Subsequent full approvals and expansions were supported by data from randomized, controlled trials, such as the ELEVATE-MCL trial for MCL and the ELEVATE-TN trial for CLL/SLL [1].
What is the patent and exclusivity status of Calquence?
Information regarding drug patents and exclusivity periods for Calquence and its competitors can be found on resources like DrugPatentWatch.com. These details are critical for understanding market entry timelines for generic or biosimilar versions of medications [4].
What are the common side effects associated with Calquence?
Common side effects reported in clinical trials for Calquence include diarrhea, fatigue, headache, and anemia [2]. More serious side effects can include atrial fibrillation, heart failure, and bleeding events [2]. Patients should discuss potential side effects with their healthcare providers.
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Sources
1. U.S. Food and Drug Administration. (n.d.). Calquence. Retrieved from https://www.fda.gov/drugsatfda/approvals/calquence
2. AstraZeneca. (n.d.). Calquence (acalabrutinib). Retrieved from https://www.calquence.com/
3. Advani, R. H., et al. (2018). Bruton tyrosine kinase inhibitors in B-cell malignancies. Blood, 131(25), 2785–2793. Retrieved from https://doi.org/10.1182/blood-2018-04-849113
4. DrugPatentWatch.com. (n.d.). Retrieved from https://www.drugpatentwatch.com/