CDSCO panel tells JnJ to submit clarification for weight based calculated fixed dose of Teclistamab

Based on the proposal presented by drug major Johnson & Johnson for the protocol amendment of the anticancer drug Teclistamab, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined that the firm should submit clarification for a weight-based calculated fixed dose of the anticancer drug Teclistamab in light of earlier trials along with other regulatory approvals for review of the committee.

This came after Johnson & Johnson presented its proposal for protocol amendment vide protocol No.64007957MMY3006, amendment 1, dated 16 Feb 2023 before the committee.

For more details, check out the link given below:

Submit Clarification For Weight-Based Calculated Fixed Dose: CDSCO Panel Tells J&J Over Teclistamab