Acalabrutinib FDA approval was granted on October 31, 2017, for treating MCL. Its approval was later expanded to include CLL and SLL. Acalabrutinib (brand name Calquence) is manufactured by AstraZeneca Pharmaceuticals.How does acalabrutinib work?
Acalabrutinib was approved by the FDA in November 2019 for the treatment of adult patients with CLL or SLL based on data from the phase 3 ELEVATE-TN (NCT02475681) and ASCEND trials. A year later, in November 2020, the BTK inhibitor also gained approval by the European Union for patients ...
英文版说明书 US FDA approves AstraZenecas Calquence (acalabrutinib) for adult patients with previously-treated mantle cell lymphoma—Accelerated approval of the selective Bruton tyrosine kinase(BTK) inhibitor in MCL marks AstraZeneca’s entry into the treatment of blood cancers—80% of patients recei...
“As our first European approval in blood cancers, [acalabrutinib] provides a new tolerable treatment option with uncompromised efficacy and the potential to positively impact the quality of life for thousands of patients living with CLL.” In November 2019, the FDA approved acalabrutinib for the...
Acalabrutinibis a highly selective and potent inhibitor of Bruton tyrosine kinase used as a therapeutic approach forchronic lymphocytic leukemia[101]. It is hypothesized thatacalabrutinibmay benefit individuals with COVID-19. A prospective off-label study was conducted on 19 hospitalized patients with...
(FDA) accelerated approval ofCalquence(acalabrutinib). The findings were presented for the first time during an oral session at the 59th American Society of Hematology (ASH) Annual Meeting & Exhibition in Atlanta, USA and demonstrate the safety profile and efficacy of acalabrutinib in the ...
Calquence (Acalabrutinib) Approved for Relapsed or Refractory Mantle-Cell Lymphoma in AdultsLisa A. Raedler
Brown, M.D., from Dana-Farber Cancer Institute in Boston, and colleagues conducted a phase 3, open-label trial involving patients with CLL aged 18 years or older with an Eastern Cooperative Oncology Group performance-status score of 0 to 2, who did not have a 17p deletion or TP53 ...
Acalabrutinib received approval for relapsed MCL patients based on a phase 2 open-label single-arm multicenter trial.43 Patients were required to have failed at least 1 prior therapy. They received single-agent acalabrutinib at 100 mg by mouth twice daily. There were 124 patients enrolled with...
ELEVATE-RR is a randomized, multicenter, open-label, phase 3 non-inferiority trial. The study enrolled 533 patients and randomized them 1:1 to receive either acalabrutinib or ibrutinib. In the acalabrutinib arm, patients were given a 100-mg dose of the drug orally twice daily...