Matching articles for "Calquence"
In Brief: Zanubrutinib (Brukinsa) for CLL or SLL (online only)
The Medical Letter on Drugs and Therapeutics • February 20, 2023; (Issue 1670)
The Bruton's tyrosine kinase (BTK) inhibitor
zanubrutinib (Brukinsa), which was previously
approved by the FDA for treatment of mantle cell
lymphoma, Waldenström's macroglobulinemia,
and relapsed or...
The Bruton's tyrosine kinase (BTK) inhibitor
zanubrutinib (Brukinsa), which was previously
approved by the FDA for treatment of mantle cell
lymphoma, Waldenström's macroglobulinemia,
and relapsed or refractory marginal zone
lymphoma, has now been approved for treatment
of chronic lymphocytic leukemia (CLL) or small
lymphocytic lymphoma (SLL) in adults. The BTK
inhibitors ibrutinib (Imbruvica) and acalabrutinib
(Calquence) were approved earlier for treatment of
CLL and SLL.
Pirtobrutinib (Jaypirca): A Fourth Bruton's Tyrosine Kinase Inhibitor for Mantle Cell Lymphoma (online only)
The Medical Letter on Drugs and Therapeutics • February 20, 2023; (Issue 1670)
The Bruton's tyrosine kinase (BTK) inhibitor
pirtobrutinib (Jaypirca – Lilly) has received
accelerated approval from the FDA for treatment of
relapsed or refractory mantle cell lymphoma (MCL) in
adults...
The Bruton's tyrosine kinase (BTK) inhibitor
pirtobrutinib (Jaypirca – Lilly) has received
accelerated approval from the FDA for treatment of
relapsed or refractory mantle cell lymphoma (MCL) in
adults who received ≥2 prior lines of systemic therapy,
including a BTK inhibitor. Accelerated approval was
based on the response rate. The BTK inhibitors
ibrutinib (Imbruvica), acalabrutinib (Calquence),
and zanubrutinib (Brukinsa) are also approved for
treatment of MCL.
In Brief: Acalabrutinib (Calquence) for Mantle Cell Lymphoma (online only)
The Medical Letter on Drugs and Therapeutics • November 5, 2018; (Issue 1559)
The FDA has approved the Bruton tyrosine kinase (BTK) inhibitor acalabrutinib (Calquence – AstraZeneca) for oral treatment of relapsed or refractory mantle cell lymphoma. Acalabrutinib is the second BTK...
The FDA has approved the Bruton tyrosine kinase (BTK) inhibitor acalabrutinib (Calquence – AstraZeneca) for oral treatment of relapsed or refractory mantle cell lymphoma. Acalabrutinib is the second BTK inhibitor to be approved for this indication; ibrutinib (Imbruvica) was approved in 2013.
Ibrutinib inhibits other kinases in addition to BTK and has been associated with severe adverse effects, particularly atrial fibrillation, infection, rash, and bleeding, that may be related to inhibition of kinases other than BTK.1 Acalabrutinib is a more selective BTK inhibitor than ibrutinib; whether this improved selectivity results in fewer adverse events is unclear.2
FDA approval of acalabrutinib was based on the results of a single-arm trial in 124 patients who had received a median of 2 previous therapies for mantle cell lymphoma. After a median follow-up of 15.2 months, 81% of patients treated with acalabrutinib 100 mg twice daily achieved an overall response and 40% achieved a complete response. The Kaplan-Meier estimated median overall survival rate at 12 months was 87%.3
The most common severe adverse events in the pivotal trial were neutropenia (10%), anemia (9%), and pneumonia (5%). There were no cases of atrial fibrillation and one case of severe hemorrhage. No head-to-head trials comparing acalabrutinib with ibrutinib are available to date.
The cost of 30 days' treatment with Calquence (100 mg bid) is $14,064 and with Imbruvica (560 mg once daily) is $12,180.4
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Ibrutinib inhibits other kinases in addition to BTK and has been associated with severe adverse effects, particularly atrial fibrillation, infection, rash, and bleeding, that may be related to inhibition of kinases other than BTK.1 Acalabrutinib is a more selective BTK inhibitor than ibrutinib; whether this improved selectivity results in fewer adverse events is unclear.2
FDA approval of acalabrutinib was based on the results of a single-arm trial in 124 patients who had received a median of 2 previous therapies for mantle cell lymphoma. After a median follow-up of 15.2 months, 81% of patients treated with acalabrutinib 100 mg twice daily achieved an overall response and 40% achieved a complete response. The Kaplan-Meier estimated median overall survival rate at 12 months was 87%.3
The most common severe adverse events in the pivotal trial were neutropenia (10%), anemia (9%), and pneumonia (5%). There were no cases of atrial fibrillation and one case of severe hemorrhage. No head-to-head trials comparing acalabrutinib with ibrutinib are available to date.
The cost of 30 days' treatment with Calquence (100 mg bid) is $14,064 and with Imbruvica (560 mg once daily) is $12,180.4
- AP Bye et al. Severe platelet dysfunction in NHL patients receiving ibrutinib is absent in patients receiving acalabrutinib. Blood Adv 2017; 1:2610.
- J Wu et al. Acalabrutinib (ACP-196): a selective second-generation BTK inhibitor. J Hematol Oncol 2016; 9:21.
- M Wang et al. Acalabrutinib in relapsed or refractory mantle cell lymphoma (ACE-LY-004): a single-arm, multicentre, phase 2 trial. Lancet 2018; 391:659.
- Approximate WAC. WAC = wholesale acquisition cost or manufacturer's published price to wholesalers; WAC represents a published catalogue or list price and may not represent an actual transactional price. Source: AnalySource® Monthly. October 5, 2018. Reprinted with permission by First Databank, Inc. All rights reserved. ©2018. www.fdbhealth.com/policies/drug-pricing-policy.
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