New Delhi: In a significant development, the drug major Dr. Reddy’s Laboratories has got a green signal from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to manufacture and market the anticancer drug Lenalidomide Capsules 25 mg for the proposed indication, “For the treatment of patients with transfusion-dependent anaemia due to low or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities and in combination with Dexamethasone for the treatment of multiple myeloma patients who have received at least one prior therapy”.
This came after the firm presented the proposal for manufacturing and marketing permission of Lenalidomide Capsule 25mg (using Lenalidomide povidone premix) along with the results of the bioequivalence (BE) study before the committee.
Lenalidomide is in a class of medications called immunomodulatory agents. It works by helping the bone marrow produce normal blood cells and killing abnormal cells in the bone marrow.
Lenalidomide acts by a novel drug mechanism—modulation of the substrate specificity of the CRL4CRBN E3 ubiquitin ligase. In multiple myeloma, lenalidomide induces the ubiquitination of IKZF1 and IKZF3 by CRL4CRBN. Subsequent proteasomal degradation of these transcription factors kills multiple myeloma cells.
Lenalidomide works by stopping cancer cells from developing and stopping blood vessels from growing in the cancer.
At the recent SEC meeting for Oncology and Hematology held on 11 May 2023, the expert panel reviewed the proposal presented by drug major Dr. Reddy’s Laboratories for manufacturing and marketing Lenalidomide Capsule 25mg (using Lenalidomide povidone premix) along with the results of the BE study before the committee.
After detailed deliberation, the committee recommended the grant of permission for the manufacturing and marketing of Lenalidomide capsule 25mg (using Lenalidomide povidone premix) for the proposed indication as under:
“For the treatment of patients with transfusion-dependent anaemia due to low or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities and in combination with Dexamethasone for the treatment of multiple myeloma patients who have received at least one prior therapy”
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