FDA approves AstraZeneca BTK inhibitor Calquence (acalabrutinib) for treatment of CLL or SLL
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Last Update: 2020-06-07
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Source: Internet
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Author: User
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today, the u.SFDA(http:// announcedapproval of AstraZeneca(http://of the BTK inhibitor Calquence (calabrutinib) as an initial or follow-up therapy for the treatment of chronic lymphatic leukemia (CLL) or small-cell lymphoma (SLL) adult patientsCalquence is a BTK inhibitor developed by AstraZeneca, which can be combined with BTK to inhibit its activityPreclinicaltrial(http://show edifier slower and specificity to BTK than the "first-in-class" BTK inhibitor ibrutinibIn 2017, Calquence has received accelerated FDA approval for second-line treatment of set cell lymphoma (MCL)Previously, the FDA has also granted Calquence Therapeutics CLL ground-breaking recognition and priority review eligibilityThe approval is based on the results of two phase 3 clinical trials in a randomized, active control groupA total of 535 patients with first-time CLL were involved in the first trial and 310 patients with treated CLL in the second trialThe results of two trials showed that Calquence's monotherapy and combination therapy significantly extended the patient's progressionless survival (PFS) compared to standard therapies
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