Acalabrutinib maleate is under clinical development by AstraZeneca and currently in the Phase I, Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Acalabrutinib maleate’s likelihood of approval (LoA) and phase transition for Burkitt Lymphoma took place on 26 Sep 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

In addition, the same event on 26 Sep 2022 increased Acalabrutinib maleate’s LoA and PTSR for Follicular Lymphoma, decreased LoA and PTSR for Marginal Zone B-cell Lymphoma, and increased LoA and PTSR for Waldenstrom Macroglobulinemia (Lymphoplasmacytic Lymphoma).

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Acalabrutinib maleate Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Acalabrutinib maleate overview

Acalabrutinib maleate (Calquence) is an anti-neoplastic agent. It is formulated as hard gelatin capsules and film coated tablets for oral route of administration. Calquence is indicated for the treatment of of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, for the treatment of patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic leukaemia (SLL) either as initial therapy or subsequent therapy.. and also in combination with obinutuzumab or as a monotherapy is indicated for the treatment of relapsed or refractory chronic lymphocytic leukemia. Calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.

Acalabrutinib is under development for the treatment of peanut food allergy, recurrent or refractory central nervous system lymphoma (CNSL), anti-MAG mediated neuropathy, Hodgkin lymphoma, multiple myeloma, Burkitt lymphoma, hairy cell leukemia, graft-versus-host disease, primary, secondary central nervous system lymphoma and secondary diffuse large B-cell lymphoma (DLBCL), first line diffuse large B-cell lymphoma, relapsed or refractory small lymphocytic lymphoma, refractory or relapsed or untreated mantle cell lymphoma, marginal zone B-cell lymphoma, Waldenstrom macroglobulinemia, recurrent glioblastoma multiforme, relapsed and refractory multiple myeloma, follicular lymphoma, marginal zone lymphoma, B-cell lymphoproliferative disorder, splenic marginal zone lymphoma nodal marginal zone lymphoma and extranodal marginal zone lymphoma, epithelial ovarian cancer, fallopian tube cancer, peritoneal cancer, follicular lymphoma and relapsed, refractory and untreated chronic lymphocytic leukemia, relapsed or refractory mantle cell lymphoma, primary mediastinal [thymic] large B-cell lymphoma (PMBCL) and other B-cell malignancies, coronavirus disease 2019 (COVID-19), primary and secondary central nervous system lymphoma. It was also under development for metastatic bladder cancer, metastatic pancreatic cancer, metastatic squamous lung adenocarcinoma, rheumatoid arthritis, metastatic urothelial carcinoma, recurrent, metastatic, unresectable head and neck squamous cell carcinoma coronavirus disease 2019 (COVID-19), pneumonia and cytokine storm.

AstraZeneca overview

AstraZeneca is a biopharmaceutical company, which is focused on discovery, production and commercialization of a range of prescription drugs. It develops products related to therapy areas such as respiratory, cardiovascular, renal and metabolic diseases, cancer, autoimmune, infection and neurological diseases. The company’s product portfolio includes biologics, prescription pharmaceuticals and vaccines. AstraZeneca sells its products through wholly-owned local marketing companies, distributors and local representative offices. The company markets its products to primary care and specialty care physicians. The COVID-19 Vaccine AstraZeneca has been approved for conditional marketing or emergency use. The company operates in Europe, the Americas, Asia, Africa and Australasia. AstraZeneca is headquartered in Cambridge, Cambridgeshire, the UK.

Quick View Acalabrutinib maleate LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Acalabrutinib maleate
Administration Pathway
  • Oral
Therapeutic Areas
  • Central Nervous System
  • Immunology
  • Infectious Disease
  • Oncology
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.