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  • Johnson & Johnson gets...

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

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-04-12T05:45:41+05:30  |  Updated On 12 April 2025 5:45 AM IST
JnJ Nipocalimab gets USFDA Fast Track designation for Sjogrens disease
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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.

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.

Also Read: No Long-Term Safety Data: CDSCO Panel Denies Novo Nordisk's proposal to amend warning statement of Semaglutide

johnson and johnsoncdscoamivantamabnon-small cell lung canceranticancer drug
Dr. Divya Colin
Dr. Divya Colin

    Doctor of Pharmacy

    Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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