CDSCO Panel Approves Johnson and Johnson's Protocol Amendment Proposal to study anti-cancer drug Amivantamab
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved the drug major Johnson and Johnson's protocol amendment proposal to study the anti-cancer drug Amivantamab (JNJ-61186372) with the condition that an interim analysis report before the LTE (long-term extension) phase shall be submitted to CDSCO.
This came after the firm presented protocol amendment 3 dated 07 August 2023, protocol no. 61186372NSC3001. This is a randomized, open-label phase 3 study of combination Amivantamab and Carboplatin-Pemetrexed therapy, compared with carboplatin-pemetrexed, in patients with EGFR Exon 20ins-mutated locally advanced or metastatic non-small cell lung cancer.
Amivantamab is an EGF and MET receptor targeted antibody indicated in the treatment of non-small cell lung cancer with an EGFR 20 exon insertion mutation.
At the recent SEC meeting for oncology held on June 18, 2024, the expert panel reviewed protocol amendment 3 dated 07 August 2023 protocol no. 61186372NSC3001 presented by the drug major Johnson and Johnson.
After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm, with the condition that an interim analysis report before the LTE phase be submitted to CDSCO.
