Matching articles for "Imbruvica"
Axatilimab (Niktimvo) for Chronic Graft-Versus-Host Disease (online only)
The Medical Letter on Drugs and Therapeutics • November 11, 2024; (Issue 1715)
Axatilimab-csfr (Niktimvo – Incyte), a colony
stimulating factor-1 receptor-blocking antibody, has
been approved by the FDA for intravenous treatment
of chronic graft-versus-host disease (cGVHD)...
Axatilimab-csfr (Niktimvo – Incyte), a colony
stimulating factor-1 receptor-blocking antibody, has
been approved by the FDA for intravenous treatment
of chronic graft-versus-host disease (cGVHD) after
failure of at least 2 lines of systemic therapy in patients
weighing ≥40 kg. Corticosteroids are generally the
first-line treatment for cGVHD. The oral kinase
inhibitors ibrutinib (Imbruvica), ruxolitinib (Jakafi),
and belumosudil (Rezurock) are also approved for
treatment of cGVHD. Extracorporeal photopheresis
has been used off-label.
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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Idelalisib (Zydelig) for Chronic Lymphocytic Leukemia and Non-Hodgkins Lymphoma (online only)
The Medical Letter on Drugs and Therapeutics • May 11, 2015; (Issue 1468)
The FDA has approved idelalisib (Zydelig – Gilead),
an oral kinase inhibitor, for use in combination with
rituximab (Rituxan) for treatment of relapsed chronic
lymphocytic leukemia (CLL). It is also...
The FDA has approved idelalisib (Zydelig – Gilead),
an oral kinase inhibitor, for use in combination with
rituximab (Rituxan) for treatment of relapsed chronic
lymphocytic leukemia (CLL). It is also approved as
monotherapy for treatment of relapsed follicular
lymphoma and relapsed small lymphocytic lymphoma
(both are subtypes of indolent non-Hodgkins
lymphoma) in patients who have received at least two
prior systemic therapies.
Obinutuzumab (Gazyva) for Chronic Lymphocytic Leukemia (online only)
The Medical Letter on Drugs and Therapeutics • November 10, 2014; (Issue 1455)
Obinutuzumab (Gazyva – Genentech), a humanized anti-CD20 monoclonal
antibody, has been approved by the FDA for use in
combination with chlorambucil (Leukeran) in patients
with previously untreated chronic...
Obinutuzumab (Gazyva – Genentech), a humanized anti-CD20 monoclonal
antibody, has been approved by the FDA for use in
combination with chlorambucil (Leukeran) in patients
with previously untreated chronic lymphocytic
leukemia (CLL). Two other anti-CD20 antibodies,
rituximab (Rituxan) and ofatumumab (Arzerra), were
previously approved for treatment of CLL.
Ibrutinib (Imbruvica) for Chronic Lymphocytic Leukemia
The Medical Letter on Drugs and Therapeutics • April 14, 2014; (Issue 1440)
The FDA has approved ibrutinib (eye broo' ti nib;
Imbruvica – Janssen/Pharmacyclics), an oral kinase
inhibitor, for second-line treatment of chronic
lymphocytic leukemia (CLL). It is the first kinase...
The FDA has approved ibrutinib (eye broo' ti nib;
Imbruvica – Janssen/Pharmacyclics), an oral kinase
inhibitor, for second-line treatment of chronic
lymphocytic leukemia (CLL). It is the first kinase inhibitor
to be approved for CLL. Ibrutinib was approved earlier
for second-line treatment of mantle cell lymphoma, a
rare form of B-cell non-Hodgkins lymphoma.