Johnson & Johnson gets CDSCO Panel for additional indication of Amivantamab Liquid Concentrate for Infusion

New Delhi: In a significant development, the drug major Johnson and Johnson has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) for an additional indication of the drug Amivantamab Liquid Concentrate for infusion 350 mg in combination with carboplatin and pemetrexed for the treatment of patients with locally advanced or metastatic non–small-cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with osimertinib.

However, this approval is subject to the condition that the firm needs to conduct a Phase IV study.

In addition, the committee recommended that the firm submit a Phase IV study protocol within three months of approval of additional indication.

This came after Johnson and Johnson presented the proposal for the grant of approval of additional indication of the drug Amivantamab Liquid Concentrate for infusion 350 mg, i.e., Amivantamab is indicated in combination with carboplatin and pemetrexed for the treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with osimertinib” based on the clinical data generated from Phase III Global Clinical Trial, where India is one of the participating countries.