Acalabrutinib review The acalabrutinib maleate formulation is relevant to both of the current indications for patients who c rrently take capsules of acalabrutinib. Jan 1, 2022 · Leukemia - Efficacy and safety in a 4-year follow-up of the ELEVATE-TN study comparing acalabrutinib with or without obinutuzumab versus obinutuzumab plus chlorambucil in treatment-naïve. 9 out of 10 from a total of 37 reviews on Drugs. Calquence (acalabrutinib) is a first-choice treatment option for people with CLL. May 1, 2025 · The combination of acalabrutinib with bendamustine-rituximab significantly improved PFS. Aug 24, 2023 · Acalabrutinib has a favorable benefit-risk profile, including lower incidence of cardiovascular-related toxicities, vs ibrutinib. The scientific review concluded that the benefit-risk ratio of acalabrutinib was positive for both indications. Jan 17, 2025 · The FDA has approved acalabrutinib (Calquence) plus bendamustine and rituximab (Rituxan; BR) for adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT). Jun 27, 2025 · Acalabrutinib had previously received approval in 2017 as a single agent for this same indication. The approval was granted by the Food and Drug Administration (FDA) after securing Priority Review. Efficacy and safety of acalabrutinib monotherapy were evaluated in a treatment-naive CLL cohort of a single-arm phase 1/2 trial (ACE-CL-001). Acalabrutinib and Its Therapeutic Potential in the Treatment of Chronic Lymphocytic Leukemia: A Short Review on Emerging Data 1. a were submitted with this supplement. Sep 26, 2024 · Acalabrutinib is one of the second-generation BTK inhibitors and offers improved selectivity, reducing off-target effects. PFS was defined as time from randomization to disease progression (per the International Workshop on CLL 2008 criteria 21) or death. Jan 16, 2025 · The FDA has approved acalabrutinib (Calquence) plus bendamustine and rituximab as a treatment option for patients with previously untreated mantle cell lymphoma (MCL) who are not eligible for autologous hematopoietic stem cell transplantation. Methods: We searched PubMed, Embase, Scopus, and Web of Science from database inception through November 15th 2019. Jan 17, 2025 · Acalabrutinib (Calquence; AstraZeneca), a second-generation Bruton tyrosine kinase inhibitor, received 2 traditional approvals from the FDA on January 16: in combination and as monotherapy for Oct 3, 2024 · “Today’s priority review acceptance reinforces the potential of [acalabrutinib] to transform outcomes in untreated mantle cell lymphoma. com. Jun 26, 2024 · Acalabrutinib-based regimens achieve long-term efficacy in patients with higher-risk CLL, across all lines of therapy. , 2020). Sep 21, 2015 · *Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present. Aims: We conducted this systematic review and meta-analysis to estimate the risk of infections associated with acalabrutinib in patients with CLL. Approval was granted approximately 14 weeks prior to the due date. Here, we report the first case of Alternaria cutaneous infection associated with acalabrutinib treatment. Oct 3, 2024 · WILMINGTON, Del. We compare the efficacy of acalabrutinib with or without obinutuzumab against chlorambucil with obinutuzumab in patients with treatment-naive chronic lymphocytic leukaemia. In this review, we elaborate on the landmark phase III trials that established a place for acalabrutinib in the treatment of patients with CLL and focus on unmet needs and future directions. Mar 21, 2021 · Adverse events for patients receiving acalabrutinib varied across trials, but the most frequent were generally headache, diarrhea, neutropenia, nausea, and infections. AE burden score allowed further comparison of the safety of acalabrutinib vs ibrutinib accounting for AE duration, recurrence, and grade. Jul 26, 2021 · Among Bruton's tyrosine kinase inhibitors, acalabrutinib has greater selectivity than ibrutinib, which we hypothesized would improve continuous therapy tolerability. The following PK parameters for acalabrutinib and its active metabolite, ACP-5862, are from the CALQUENCE® capsule label, and the food effect results and the drug-drug interaction study Mar 1, 2025 · Indeed, stopping acalabrutinib therapy within the first year in the frontline setting was associated with an increased risk of CLL-related mortality in the registration trial ELEVATE-TN. 75 to 2. Nov 5, 2020 · Herein, we conducted a systematic review and network meta-analysis of AEs from prospective clinical trials of ibrutinib and acalabrutinib in B-cell lymphoproliferative disorders to compare their safety profile. NDA 216387 provides for the use of Calquence (acalabrutinib) tablets for the following indications which, for administrative purposes, we have designated as follows: Read 1 user reviews of Acalabrutinib Oral. 5 times the approved recommended single dose) in patients with B-cell malignancies. We would like to show you a description here but the site won’t allow us. The recent application was granted both priority review and orphan drug designation. Average rating: 2. Dec 4, 2020 · Acalabrutinib is a second generation Bruton's tyrosine kinase inhibitor and was recently approved in the treatment of chronic lymphocytic leukaemia. Mar 17, 2022 · Areas covered: : This review examines the activity of acalabrutinib in treating treatment-naïve and relapsed refractory CLL and its toxicity profile when compared to ibrutinib and other drugs. Oct 3, 2024 · The FDA has granted Priority Review to acalabrutinib for the treatment of adult patients with previously untreated mantle cell lymphoma. Apr 18, 2020 · Acalabrutinib is a selective, covalent Bruton tyrosine-kinase inhibitor with activity in chronic lymphocytic leukaemia. After initial literature review 12 studies were chosen for evaluation in this meta-analysis. Since the ECHO trial was conducted during the COVID-19 pandemic, the researchers also censored for COVID-19-related deaths. Acalabrutinib is a second-generation Bruton tyrosine kinase inhibitor (BTKi) that was developed after ibrutinib, the Cumulative review of cardiac failure with acalabrutinib in the treatment of chronic lymphocytic leukemia using data from clinical trials and postmarketing experience Mar 12, 2025 · Another case of invasive nervous system infection in patients receiving long-term acalabrutinib treatment has been reported, but the fungal strain, Aspergillus -like, has not been investigated (20). In the absence of direct comparative evidence, the CADTH clinical review team concluded that the results of the network meta-analyses (NMAs) and matching-adjusted indirect comparisons (MAICs) comparing zanubrutinib with ibrutinib and with acalabrutinib were uncertain due to the reduction in sample sizes in both the TN and r/r populations during Jan 17, 2025 · AstraZeneca’s CALQUENCE ® (acalabrutinib) in combination with bendamustine and rituximab has been approved in the US for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation. Refer to complete clinical pharmacology review for analysis of drug-drug interaction data, bioequivalence, and bioavailabi ity ata provided with this This review used the Real-Time Oncology Review (RTOR) and Assessment Aid pilot programs, which streamlined data submission prior to the filing of the entire clinical applications, and facilitated Calquence User Reviews & Ratings Calquence has an average rating of 8. Jan 25, 2023 · Calquence (acalabrutinib) is an oral medication used to treat blood and bone marrow cancers called mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), and small lymphocytic lymphoma (SLL). The NMA was limited by heterogeneity in patient baseline characteristics across trials, variable treatment regimens, and short study follo … Reviews and ratings for Acalabrutinib. 10 Additionally, caution is advised when co-administering acalabrutinib with strong CYP3A inhibitors or inducers, which may affect acalabrutinib plasma This article summarizes the scientific review of the application leading to the regulatory approval of acalabrutinib in the EU. After doing so, the progression-free survival May 1, 2020 · In November 2019, the FDA approved acalabrutinib for adults with CLL or small lymphocytic lymphoma (SLL), regardless of age and comorbidities, in a decision partly based on the results from Nov 1, 2021 · In this first direct comparison of less versus more selective Bruton's tyrosine kinase inhibitors in CLL, acalabrutinib demonstrated noninferior PFS with fewer cardiovascular adverse events. Acalabrutinib was given continuously until time of progression or unacceptable toxicity (for the first 6 months in combination with obinutuzumab by infusion in that arm), whereas chlorambucil with obinutuzumab was given as a standard fixed The FDA granted supplemental approval to Calquence (acalabrutinib) for the treatment of adults with chronic lymphocytic leukemia or small lymphocytic lymphoma Jan 9, 2025 · Durable responses from acalabrutinib in combination with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone (R-CHOP) as first line therapy for patients with diffuse large B-cell lymphoma (DLBCL): the accept phase Ib/II single arm study [abstract] Feb 10, 2021 · This article summarizes the EMA scientific review of the application leading to regulatory approval for acalabrutinib for treatment of leukemia. Acalabrutinib was shown to be efficacious and less toxic than ibrutinib in a head-to-head trial in chronic lymphocytic Jul 26, 2021 · In the article accompanying this editorial, ELEVATE RR study is a phase III, randomized, open-label, noninferiority study with a primary end point of independent review committee-assessed noninferiority of PFS between acalabrutinib and ibrutinib. Feb 20, 2025 · Acalabrutinib, venetoclax, and obinutuzumab is a highly active, time-limited frontline therapy for patients with high-risk CLL. Acalabrutinib has been associated with mild-to-moderate serum enzyme elevations during therapy but has not bee … Oct 4, 2024 · The FDA granted a priority review to acalabrutinib for the treatment of previously untreated adults with mantle cell lymphoma. Sep 11, 2025 · The primary end point was independent review committee (IRC) assessment of PFS for acalabrutinib-obinutuzumab vs chlorambucil-obinutuzumab. We conducted an open-label, randomized, noninferiority, phase III trial comparing acalabrutinib and ibrutinib in patients with chronic Abstract Acalabrutinib has demonstrated significant efficacy and safety in relapsed chronic lymphocytic leukemia (CLL). Clinical benefit of acalabrutinib with bendamustine-rituximab was achieved with manageable toxicity. Oct 3, 2024 · The FDA granted priority review to acalabrutinib for previously untreated mantle cell lymphoma. Acalabrutinib was associated with favorable PFS and OS compared with frontline CLL therapies and ranked highest in treatment efficacy over the other comparators. Jun 6, 2025 · A fixed-duration regimen of AstraZeneca’s Calquence (acalabrutinib) in combination with venetoclax, with or without obinutuzumab, has been approved in the European Union (EU) for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). 32 reviews submitted with a 8. Nov 2, 2023 · Acalabrutinib is an irreversible, second generation BTKi that is more selective and potent than ibrutinib. 5/5 for effectiveness, ease of use, and satisfaction. *Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013. The findings showed that acalabrutinib is a highly effective therapeutic intervention, especially among patients suffering from CLL. This review examines the activity of acalabrutinib in treating treatment-naïve and relapsed refractory CLL and its toxicity profile when compared to ibrutinib and other drugs. 1 Pharmacology and Clinical Pharmacokinetics Acalabrutinib is a small-molecule inhibitor of Bruton tyrosine kinase (BTK). The U. The NDA is based on results from the Phase II ACE-LY-004 However, the risk of infection with acalabrutinib is unknown in patients with CLL. 6 The study enrolled 533 patients with previously treated CLL and prognostic factors of del (17p) (45%) and/or del (11q) (64%), which were both Acalabrutinib exhibits dose-proportionality, and both acalabrutinib and its active metabolite, ACP-5862, exposures increase with dose across a dose range of 75 to 250 mg (0. Jan 16, 2025 · On January 16, 2025, the FDA granted traditional approval to acalabrutinib (Calquence, AstraZeneca) with bendamustine and rituximab for adults with previously untreated mantle cell lymphoma (MCL Dec 4, 2020 · Acalabrutinib, the initial second-generation BTKi to earn approval from the US Food and Drug Administration, demonstrates improved kinase selectivity for BTK, with commonly observed adverse reactions including infection, headache, and diarrhea. Acalabrutinib is a second generation, orally bioavailable, Bruton Tyrosine Kinase inhibitor that is indicated for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy 4 days ago · The FDA will give AstraZeneca’s acalabrutinib a fast review in a rare blood cancer, as the company hopes to shake off MYSTIC disappointment. The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer Oct 17, 2023 · Emerging data suggest several newer BTK inhibitors (eg, acalabrutinib, zanubrutinib) are still associated with cardiotoxic risks. 8 out of 10 from a total of 44 reviews on Drugs. Secondary end points included PFS with acalabrutinib along with venetoclax and obinutuzumab, overall survival, and undetectable measurable residual disease. 2 It was PubMeb, Embase, and Cochrane Library databases were searched using the keywords: Acalabrutinib, Acalabrutinib Monotherapy, Tyrosine Kinase Inhibitor, and Relapsed/Refractory (R/R) CLL. 1 Acalabrutinib is a second generation Bruton's tyrosine kinase inhibitor and was recently approved in the treatment of chronic lymphocytic leukaemia. Nonclinical Aspects Acalabrutinib is a selective inhibitor of BTK, a Tec family tyrosine kinase normally expressed in B cells, myeloid cells, mast cells, and platelets. Jul 29, 2025 · A supplemental new drug application for all-oral, fixed-duration acalabrutinib plus venetoclax in treatment-naive CLL has been submitted to the FDA. Introduction NDA 216387 was submitted by AstraZeneca UK Ltd. , October 03, 2024--AstraZeneca’s supplemental New Drug Application (sNDA) for CALQUENCE® (acalabrutinib) has been accepted and granted Priority Review in the US for the Jan 6, 2025 · We summarize results from the interim analysis of the phase III randomized AMPLIFY trial evaluating the safety and efficacy of acalabrutinib-venetoclax with or without obinutuzumab in CLL. This systematic review and meta-analysis analyze data from multiple clinical trials to assess acalabrutinib efficacy and safety among patients with CLL. Acalabrutinib User Reviews & Ratings Brand names: Calquence Acalabrutinib has an average rating of 8. Feb 19, 2025 · As reported in The New England Journal of Medicine by Jennifer Brown, MD, and colleagues, the phase III AMPLIFY trial found that fixed-duration acalabrutinib combined with venetoclax or venetoclax/obinutuzumab improved progression-free survival vs chemoimmunotherapy in fit, previously untreated patients with chronic lymphocytic leukemia (CLL). Nov 21, 2019 · View full prescribing information for acalabrutinib. 89% of reviewers reported a positive experience, while 3% reported a negative experience. 8 average score (Page 2). May 14, 2021 · Acalabrutinib Mechanism of Action and Pharmacokinetics Acalabrutinib is a highly selective, potent, covalent inhibitor of BTK with minimal off-target activity (16), having a narrower spectrum of kinase inhibition on kinome analysis than observed with ibrutinib. We undertook a systematic review and meta-analysis of randomized FDA granted Breakthrough Therapy, Orphan Drug designation, and priority review to acalabrutinib for this indication. Apr 18, 2020 · Patients received acalabrutinib, acalabrutinib with obinutuzumab, or chlorambucil with obinutuzumab. Depending on your situation, it can be used alone or with another treatment called Gazyva (obinutuzumab). 40 reviews submitted with a 8. 2. It has a 2-pyridylbenzamide moiety and an electrophilic 2-butynamide moiety that are involved in covalent binding to the cysteine (C Oct 4, 2024 · Find patient medical information for Calquence (acalabrutinib) on WebMD including its uses, side effects and safety, interactions, pictures, warnings, and user ratings Jul 29, 2025 · AbbVie seeks FDA approval for a groundbreaking oral treatment combining venetoclax and acalabrutinib, promising a new era in CLL care. Jan 28, 2016 · Acalabrutinib (ACP-196) is a more selective, irreversible BTK inhibitor that is specifically designed to improve on the safety and efficacy of first-generation BTK inhibitors. Data from phase 3, randomized, controlled trials of acalabrutinib, as monotherapy or in combination with obinutuzumab, in patients with treatment-naive (TN) and relapsed Acalabrutinib, a second-generation and more selective Bruton's tyrosine kinase inhibitor, was developed to potentiate efficacy while minimizing ibrutinib-associated side effects. Food and Drug Administration (FDA) for treatment-naive (TN) and relapsed/refractory (R/R) use for patients with chronic lymphocytic leukemia (CLL) in November 2019 following the phase III ASCEND and ELEVATE-TN registration trials. This meta-analysis investigated the efficacy, outcomes, and hematologic adverse effects of acalabrutinib in the treatment of relapsed/refractory CLL. This review used the Real-Time Oncology Review (RTOR) and Assessment Aid pilot programs, which streamlined data submission prior to the filing of the entire clinical applications, and facilitated discussions among the regulatory agencies. However, there are some uncertainties regarding the risk of infections, especially pneumonia, from different BTKi with varied immunomodulatory effects on the innate and adaptive immune system. Oct 3, 2024 · Submission to be reviewed under Project Orbis AstraZeneca’s supplemental New Drug Application (sNDA) for Calquence (acalabrutinib) has been accepted and granted Priority Review in the US for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL). The supplemental new drug application was granted priority review in October 2024. 7/5 for effectiveness, ease of use, and satisfaction. Acalabrutinib Mechanism of Action and Pharmacokinetics Acalabrutinib is a highly selective, potent, covalent inhibitor of BTK with minimal off-target activity (16), having a narrower spectrum of kinase inhibition on kinome analysis than observed with ibrutinib. Meta-analysis and follow up meta-regression models were completed. May 1, 2025 · The combination of the Bruton tyrosine kinase inhibitor ibrutinib with bendamustine-rituximab for first-line treatment of mantle cell lymphoma (MCL) prolonged progression-free survival (PFS), but without improvement in overall survival (OS), likely because of toxicity. Jan 28, 2025 · In this large, real-world comparison of the efficacy and safety profiles of acalabrutinib and ibrutinib, we illustrate the potential benefits of acalabrutinib compared with ibrutinib for both overall survival and reduced key AEs. Jan 19, 2025 · AstraZeneca’s CALQUENCE (acalabrutinib) in combination with bendamustine and rituximab was approved in the US for the treatment of adult patients with previously untreated mantle cell lymphoma. We undertook a systematic review and meta‐analysis of randomised controlled trials to determine the Nov 5, 2024 · Fixed-Duration Acalabrutinib Plus Venetoclax with or without Obinutuzumab Versus Chemoimmunotherapy for First-Line Treatment of Chronic Lymphocytic Leukemia: Interim Analysis of the Multicenter, Open-Label, Randomized, Phase 3 AMPLIFY Trial Nov 2, 2023 · Background: Acalabrutinib is a second-generation Bruton tyrosine kinase inhibitor (BTKi) approved by the Food and Drug Administration for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). 1 In October 2024, the FDA granted acalabrutinib priority review and set a Prescription Drug User Fee Act date in the first quarter or 2025. for Acalabrutinib Maleate 100 mg Tablets in accordance with section 505(b)(1) of the Food, Drug and Cosmetic Act. Food and Drug Administration today granted accelerated approval to Calquence (acalabrutinib) for the treatment of adults with mantle cell lymphoma who have received at least one prior Mar 1, 2020 · Acalabrutinib and Its Therapeutic Potential in the Treatment of Chronic Lymphocytic Leukemia: A Short Review on Emerging Data March 2020 Cancer Management and Research Volume 12:2079-2085 Read 5 user reviews of Calquence (acalabrutinib). It has a 2-pyridylbenzamide moiety and an electrophilic 2-butynamide moiety that are involved in covalent binding to the cysteine (C Nov 5, 2024 · Association Between Dose Reduction and Duration of Therapy in Patients Receiving Ibrutinib or Acalabrutinib for Chronic Lymphocytic Leukemia: A Medical Chart Review Study Mazyar Shadman, Lindsey Roeker, Subsequent phase 3 studies, ASCEND and ELEVATE-TN, compared acalabrutinib mono-therapy or combination acalabrutinib and obinutuzumab to standard of care treatments and demonstrated acalabrutinib’s improved ef cacy and tolerability. Oct 3, 2024 · Acalabrutinib, a BTK inhibitor, has shown promising results in treating mantle cell lymphoma, with the FDA granting it priority review. Analytes to measure: Acalabrutinib and active metabolite, ACP-5862 (M27), in plasma Submit the metabolite data as supportive evidence of comparable therapeutic outcome. Females of reproductive potential should use non-hormonal contraception during the study and continue to use effective contraception for one week after the last dose. Aug 19, 2024 · Additionally, as mentioned throughout this review, rates of atrial fibrillation are lower with acalabrutinib and zanubrutinib. 89% of reviewers reported a positive experience, while 5% reported a negative experience. Findings from the phase 3 ECHO trial (NCT02972840) support the Jun 9, 2025 · The EU commission has approved acalabrutinib in combination with venetoclax, with or without obinutuzumab, for the frontline treatment of CLL. The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Abstract Acalabrutinib was approved by the U. Apr 22, 2025 · Cumulative review of cardiac failure with acalabrutinib in the treatment of chronic lymphocytic leukemia using data from clinical trials and postmarketing experience Department of Cardiology, Center for Translational Cardiology and Pragmatic Randomized Trials, Copenhagen University Hospital – Herlev and Gentofte, Hellerup, Denmark Jun 11, 2025 · An NMA of BTKis found zanubrutinib to be the most efficacious treatment for patients with high-risk R/R CLL. This review examines the current state of evidence, including incidence rates, risk factors, mechanisms, and management strategies of cardiovascular toxicities with BTK inhibitors and other CLL therapies. 9 average score. S. It was based on results from the ECHO Phase III trial, which had been presented at the European Apr 24, 2025 · Bruton tyrosine kinase inhibitors (BTKi) are utilized in the front-line setting as well as for relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL). Mar 21, 2021 · Acalabrutinib is an oral inhibitor of Bruton’s tyrosine kinase that is used in the therapy of B cell malignancies including refractory mantle cell lymphoma and chronic lymphocytic leukemia. Average rating: 4. Currently, a phase 3 study is fi ongoing to compare acalabrutinib to ibrutinib monotherapy (NCT02477696). chemoimmunotherapy) in the intention-to-treat population, assessed by blinded independent central review. 7 average score (Page 2). The following is a summary of the clinical pharmacokinetics (PK) of acalabrutinib. Safety profile of acalabrutinib in patients with higher-risk CLL was similar to the overall safety profile of acalabrutinib. Zanubrutinib demonstrated reduced risk of progression/death compared to ibrutinib, acalabrutinib, and bendamustine or idelalisib+rituximab. We undertook a systematic review and meta‐analysis of randomised controlled trials to determine Aug 2, 2017 · 02 August 2017 AstraZeneca and its haematology research and development centre of excellence, Acerta Pharma, today announced that the US Food and Drug Administration (FDA) has accepted and granted Priority Review for the New Drug Application (NDA) for acalabrutinib, a highly-selective, potent, Bruton tyrosine kinase (BTK) inhibitor. Mar 11, 2021 · As summarized in a recent review on dermatological side effects, rash occurs in 13–27% (0–3% grade 3) of patients treated with ibrutinib, as compared to 15–18% and 13–18% in patients receiving acalabrutinib or zanubrutinib, respectively (Sibaud et al. The newer second-generation BTKi Mar 26, 2025 · The prognosis for patients with Chronic Lymphocytic Leukemia (CLL) modified Rai stage IV treated with acalabrutinib is generally favorable, with significant improvements in survival outcomes compared to traditional chemotherapy, as evidenced by the 5-year follow-up analysis of ELEVATE-TN, which showed superior efficacy for acalabrutinib Feb 20, 2025 · The primary end point was progression-free survival (acalabrutinib-venetoclax vs. Feb 5, 2025 · Whether fixed-duration acalabrutinib–venetoclax (with or without obinutuzumab) would result in better progression-free survival than chemoimmunotherapy in patients with untreated chronic The present review updated the clinical information regarding the efficacy and safety profile of acalabrutinib in the management of CLL. MULTI-DISCIPLINE REVIEW Summary Review Office Director Cross Discipline Team Leader Review Clinical Review Non-Clinical Review Statistical Review Clinical Pharmacology Review NDA/BLA Multi-disciplinary Review and Evaluation {NDA 210259} {CALQUENCE, acalabrutinib} 1 Version date: February 1, 2016 for initial rollout (NME/original BLA reviews) We would like to show you a description here but the site won’t allow us. 36 reviews submitted with a 8. Data from the ECHO trial showed [acalabrutinib] plus chemoimmunotherapy significantly delayed disease progression and showed a trend of improved survival in patients with this currently incurable blood cancer. Reviews and ratings for Acalabrutinib when used in the treatment of chronic lymphocytic leukemia. Apr 30, 2025 · The trial’s primary end point was PFS with acalabrutinib and venetoclax per the independent review committee. It was based Oct 3, 2024 · WILMINGTON, Del. , October 3, 2024 – AstraZeneca’s supplemental New Drug Application (sNDA) for CALQUENCE ® (acalabrutinib) has been accepted and granted Priority Review in the US for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL). hnh erydzf tic dtt asxokz hcof tgeg ryywi tsrct cxysi kmnv swabl yvekb lavl frkzxll