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.
The committee noted that the proposed indication is approved in the US, EU, UK, Switzerland, and Australia.
Amivantamab, a bispecific antibody, works by targeting both EGFR and MET receptors, inhibiting ligand binding, promoting receptor degradation, and activating immune cells to destroy cancer cells through mechanisms like antibody-dependent cellular cytotoxicity (ADCC) and trogocytosis.
Amivantamab has been approved for the treatment of patients with advanced non–small-cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertions who have had disease progression during or after platinum-based chemotherapy.
Amivantamab-vmjw injection is used in combination with other chemotherapy medications as a first treatment for certain types of non-small cell lung cancer (NSCLC) that has spread to nearby tissues or to other parts of the body.
At the recent SEC meeting for Oncology held on 11th March 2025, the expert panel reviewed the proposal for the grant of approval of additional indication of the drug Amivantamab Liquid Concentrate for infusion (350 mg).
After detailed deliberation, the committee recommended approval for the proposed additional indication with the condition to conduct a Phase IV study.
Accordingly, the expert panel suggested that the firm should submit the Phase IV study protocol within three months of approval of the additional indication.
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