Full Answer
What is the efficacy of acalabrutinib in CLL?
ELEVATE-TNrandomized 535 patients with previously untreated CLL to one of three arms: acalabrutinib monotherapy, acalabrutinib plus obinutuzumab, or obinutuzumab plus chlorambucil. With a median follow-up of 28.3 months, PFS was significantly improved in both acalabrutinib arms.
Is acalabrutinib safe to take?
Acalabrutinib is a breakthrough in the treatment of CLL. It is generally a safe medication, but all medications have risks. By educating yourself and listening to your body you will likely benefit from this drug and be able to identify potential problems and risks in your treatment.
Can I take allopurinol when I start acalabrutinib?
Your provider may start you on the anti-gout medication allopurinol when you start acalabrutinib because there is a possibility that the drug may cause a phenomenon known as Tumor Lysis Syndrome (TLS). In TLS the malignant cells rupture and, in doing so, release large quantities of uric acid.
What is acalabrutinib (Calquence)?
Acalabrutinib (a-cal-a-broo-ti-nib), which is marketed under the tradename of Calquence® in the U.S. and Canada, is a second-generation small molecule inhibitor of Bruton’s tyrosine kinase (BTK).
When was acalabrutinib approved for CLL?
In November 2019, the FDA approved acalabrutinib for the treatment of adult patients with CLL or small lymphocytic leukemia based on data from ELEVATE-TN and ASCEND. The BTK inhibitor is also approved for CLL in several other countries worldwide, according to AstraZeneca.
When was acalabrutinib approved by FDA?
Development timeline for CalquenceDateArticleOct 31, 2017Approval FDA Approves Calquence (acalabrutinib) for Adults with Mantle Cell LymphomaAug 2, 2017US FDA Accepts Regulatory Submission for Acalabrutinib and Grants Priority Review5 more rows•Jan 28, 2021
When was Calquence FDA approved for CLL?
On November 21, 2019, the FDA approved acalabrutinib (Calquence; AstraZeneca) as initial or subsequent therapy for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Is acalabrutinib approved for CLL?
Treatment with acalabrutinib is already approved for use in patients with CLL. Since ibrutinib is not always tolerated well by patients, acalabrutinib has positioned itself as an effective alternative treatment option.
How long has CALQUENCE been around?
Calquence was granted Breakthrough Therapy Designation by the FDA in August 2017 for the treatment of adult patients with MCL who have received at least one prior therapy.
Is CALQUENCE FDA approved?
CALQUENCE was approved under FDA's accelerated approval program, which provides earlier patient access to a promising new drug while the company continues to conduct clinical trials to confirm that the drug works well.
Is acalabrutinib better than Ibrutinib?
Abstract. Purpose: Among Bruton's tyrosine kinase inhibitors, acalabrutinib has greater selectivity than ibrutinib, which we hypothesized would improve continuous therapy tolerability.
Is CALQUENCE better than Imbruvica?
Acalabrutinib (Calquence) was found to have a lower incidence of cardiovascular-related toxicities and a lower toxicity burden compared with ibrutinib (Imbruvica) in patients with chronic lymphocytic leukemia (CLL), according to John Seymour, MD, who added that because of these data, the former BTK inhibitor may be the ...
Can you drink alcohol while taking CALQUENCE?
Alcohol use and Calquence There's no known interaction between alcohol and Calquence. But if you're taking Calquence with Gazyva (obinutuzumab) for chronic lymphocytic leukemia or small lymphocytic lymphoma, you should avoid alcohol.
How is CLL 2020 treated?
For patients with progressive CLL after venetoclax, treatment options include B-cell receptor pathway inhibitors (BCRis), allogeneic stem cell transplantation (SCT), chimeric antigen receptor (CAR) T-cells, and venetoclax re-treatment for those with disease relapsing after time-limited therapy.
How long is treatment with acalabrutinib?
Acalabrutinib was administered for a median of 52 months (range, 0.2-60); the overall median time on treatment was 53 months (range, 1-59) (56 months for 200 mg once daily [n = 37] and 50 months for 100 mg twice daily [n = 62]).
How long do you take acalabrutinib?
Acalabrutinib in Combination with Obinutuzumab: For patients with previously untreated CLL or SLL, the recommended dose is 100 mg taken orally approximately every 12 hours until disease progression or unacceptable toxicity. Start acalabrutinib at cycle 1 (each cycle is 28 days).
What is the BTK inhibitor for mantle cell lymphoma?
Calquence (acalabrutinib) is a highly selective, potent, Bruton tyrosine kinase (BTK) inhibitor for the treatment of mantle cell lymphoma (MCL), and chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma.
What is Calquence BTK?
Calquence (acalabrutinib) is a highly selective, potent, Bruton tyrosine kinase (BTK) inhibitor for the treatment of mantle cell lymphoma (MCL), and chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma.
What is acalabrutinib?
and Canada, is a second-generation small molecule inhibitor of Bruton’s tyrosine kinase (BTK). Upon oral administration, acalabrutinib binds to and irreversibly inhibits the activity of BTK which prevents both B-cell activation ...
Which antibiotics have the same effect as acalabrutinib?
In addition, the antibiotics clarithromycin and telithromycin and the antidepressant nefazodone have the same effect. On the opposite side are drugs that induce the enzyme that metabolizes acalabrutinib and reduces the blood levels and may render the drug sub-therapeutic.
What drug inhibits the enzyme that metabolizes acalabrutinib?
I will only discuss the most significant. Many HIV and antifungal drugs inhibit the enzyme that metabolizes acalabrutinib and result in increased blood levels and side effects. The HIV drugs can be recognized because they end in “Vir” and the antifungals end in “Zole”.
How much aspirin is equivalent to acalabrutinib?
Acalabrutinib has a mild anti-coagulant effect essentially equivalent to 325mg of aspirin. It is important that you provide a complete list of medications that includes any nutritional supplements or over-the-counter medications to your provider.
What supplements can I take with acalabrutinib?
In addition, several herbal products can enhance the anti-coagulant properties of acalabrutinib including Omega-3 Fatty Acids (Fish-Oil), Flaxseed Oil, Vitamin E, and Curcumin. Of course, if you are on any anticoagulant or antiplatelet therapy your medical team may need to adjust or eliminate your current therapy.
Can you adjust acalabrutinib for renal failure?
Your medical team may adjust the dose downward depending upon such factors as adverse side effects or if you have known liver failure. At present, there is no recommended dosage adjustment for renal failure patients however the use of acalabrutinib in End Stage Renal Disease and dialysis has not been studied.
Can grapefruit be used with acalabrutinib?
There are some serious food interactions to consider as well. Grapefruit, grapefruit juice and Seville oranges inhibit the enzyme that metabolizes acalabrutinib and the drug levels increase, risking worsening of potential side effects. Seville oranges are often used to make orange marmalade and should be avoided.
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