New Delhi: In a significant development, granting the proposal presented by drug major AstraZeneca Pharma India, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved import and marketing of anticancer drug, Acalabrutinib Tablets 100 mg.
This came in line with the proposal presented by AstraZeneca Pharma India for grant of permission to import and market of Acalabrutinib Tablets 100 mg.
Acalabrutinib is a Bruton tyrosine kinase inhibitor used to treat mantle cell lymphoma, chronic lymphocytic leukemia, and small lymphocytic lymphoma.
Earlier, the Medical Dialogues Team had reported that the US Food and Drug Administration (USFDA) had approved AstraZeneca’s new tablet formulation of Calquence (acalabrutinib) for all current indications, including adult patients with chronic lymphocytic leukaemia (CLL), small lymphocytic lymphoma (SLL) and for patients with relapsed or refractory mantle cell lymphoma (MCL).
The approval by the US Food and Drug Administration (USFDA) was based on results from the ELEVATE-PLUS trials presented during the 63rd American Society of Hematology (ASH) Annual Meeting & Exposition in December 2021.
Bruton Tyrosine Kinase (BTK) is a signalling molecule of the B-cell antigen receptor and cytokine receptor pathways. Such BTK signaling causes the activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion.
Acalabrutinib is a small molecule inhibitor of BTK. Both acalabrutinib and its active metabolite, ACP-5862, act to form a covalent bond with a cysteine residue (Cys481) in the BTK active site, leading to inhibition of BTK enzymatic activity. As a result, acalabrutinib inhibits BTK-mediated activation of downstream signaling proteins CD86 and CD69, which ultimately inhibits malignant B-cell proliferation and survival.
At the recent SEC meeting for Oncology & Haematology dated 25.11.2022, the expert panel reviewed the proposal presented by AstraZeneca Pharma India for grant of permission to import and market of Acalabrutinib Tablets 100 mg.
After detailed deliberation, the committee recommended the approval of permission for import and marketing of Acalabrutinib Tablets 100 mg.