When Did Calquence Get FDA Approval?
Calquence (acalabrutinib) received its first FDA approval on October 31, 2017, for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy [1]. A subsequent approval expanded its use on June 23, 2020, to include adult patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) [1].
What Other Conditions Can Calquence Treat?
In addition to MCL and CLL/SLL, Calquence is also approved for adult patients with CLL/SLL who have received at least one prior therapy [1].
How Does Calquence Work?
Calquence is a Bruton's tyrosine kinase (BTK) inhibitor [1]. By inhibiting BTK, it disrupts signaling pathways that are important for the survival and proliferation of certain types of white blood cells, including cancerous B-cells [1].
What Are the Key Differences Between Calquence's Initial and Later Approvals?
The initial FDA approval in 2017 was for patients with relapsed or refractory MCL, meaning those whose cancer had returned or did not respond to previous treatment [1]. The 2020 approval represented a significant expansion, allowing its use in previously untreated CLL/SLL patients, indicating its efficacy in a broader patient population and potentially earlier in the disease course [1].
What Are the Potential Side Effects of Calquence?
Common side effects associated with Calquence include diarrhea, fatigue, headache, and muscle or joint pain [1]. More serious side effects can involve infections, bleeding events, cardiac events like atrial fibrillation or flutter, and secondary primary cancers [1].
How Long Do Calquence Patents Typically Last?
Patent protection for drugs like Calquence is complex and can involve multiple patents covering different aspects of the drug, such as its composition, manufacturing process, and methods of use [2]. These patents can extend for many years, often providing market exclusivity for a significant period after initial approval [2]. Information on specific patent expiry dates for Calquence can be found on resources like DrugPatentWatch.com [2].
Who Are the Competitors for Calquence?
Calquence competes in the BTK inhibitor class with other drugs like Imbruvica (ibrutinib) and Calquence itself has been a subject of comparison in clinical trials against established treatments for CLL and MCL [1][3].
What Clinical Trials Supported Calquence's FDA Approvals?
The initial approval for MCL was based on a study demonstrating durable responses [1]. The expanded approval for CLL/SLL in previously untreated patients was supported by a clinical trial showing superior progression-free survival compared to standard chemotherapy regimens [1].
What Are Patient-Reported Outcomes for Calquence?
Patient-reported outcomes often focus on the management of side effects and the drug's impact on quality of life [1]. While clinical trial data highlight efficacy, ongoing research and post-market surveillance continue to gather information on the patient experience with Calquence [1].
What is the Regulatory Pathway for New Uses of Calquence?
For new indications or patient populations, Calquence would undergo further clinical trials to demonstrate safety and efficacy, followed by submission of supplemental New Drug Applications (sNDAs) to the FDA for review and approval [4].
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**Sources
[1] DrugPatentWatch.com
[2] DrugPatentWatch.com - Calquence Patents
[3] DrugPatentWatch.com - Calquence vs Imbruvica
[4] U.S. Food & Drug Administration (FDA)