Veeda Clinical Research Gets Expert Committee Nod To Conduct BA/BE Study Of Ibrutinib For Export
New Delhi: Veeda Clinical Research Limited got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the BA/BE study of the the anti-cancer drug Ibrutinib.
This came after the firm presented the BA/BE study Protocol No. 25-VIN-0162, Version No. 01, Protocol Date 16-APR-2025 for conducting BA/BE study for export purpose only, before the committee.
Ibrutinib is in a class of medications called kinase inhibitors. Ibrutinib is a targeted therapy that works by inhibiting Bruton's tyrosine kinase (BTK), a protein crucial for B-cell receptor signaling. By blocking BTK, ibrutinib disrupts the signaling pathways that promote B-cell survival and proliferation, ultimately leading to the death of cancerous B-cells. This mechanism of action makes ibrutinib effective in treating various B-cell malignancies, including chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL).
Ibrutinib is used to treat adults with chronic lymphocytic leukemia (CLL; a type of cancer that begins in the white blood cells) and small lymphocytic lymphoma (SLL; a type of cancer that begins mostly in the lymph nodes).
At the recent SEC meeting for Oncology held on 17th July 2025, the expert panel reviewed the the BA/BE study Protocol No. 25-VIN-0162, Version No. 01, Protocol Date 16-APR-2025 for conducting BA/BE study for export purpose only, before the committee.
After detailed deliberation, the committee recommended for grant of permission to conduct the BA/BE study for export purpose only.
