CDSCO Panel Seeks Safety Data on 5% Lenalidomide TDS Before Clearing 8% Patch Trial
New Delhi: The Subject Expert Committee (SEC) under the Oncology division of the Central Drugs Standard Control Organisation (CDSCO) has not granted approval to the proposal submitted by Raptim Research Pvt. Ltd. for conducting a bioavailability/bioequivalence (BA/BE) study of Lenalidomide TDS 8% - LLD-TDS-009 patch, citing the requirement for submission of safety data on the lower-strength formulation before proceeding.
The matter was discussed during the SEC Oncology meeting held on 8th July 2025.
Raptim Research presented the BA/BE study protocol PR/BE/24/370, Version 00, dated 15th January 2025, for the Lenalidomide TDS 8% patch (50 cm² with 81 cm² overlay). The protocol was submitted for approval concerning studies intended for export purposes only.
Following detailed discussions, the committee advised that the firm should submit safety data of low-strength Lenalidomide TDS 5% using Derma Roller technology before initiating any studies involving the higher-strength Lenalidomide TDS 8% formulation in healthy human subjects.
Lenalidomide is a widely used immunomodulatory agent, indicated in the treatment of several hematological malignancies, including multiple myeloma. The transdermal delivery system (TDS) approach using Derma Roller technology aims to enhance the absorption of Lenalidomide through the skin, offering a potential alternative route of administration.
The SEC’s observations were officially recorded as part of the recommendations issued during the Oncology division’s meeting on 8th July 2025. The committee’s review focused on ensuring adequate safety data is available when new delivery systems like Derma Roller technology are used, particularly in healthy subjects during bioequivalence studies.
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