Johnson & Johnson Gets CDSCO Panel Nod to Study anti-cancer drug Amivantamab

New Delhi: The drug major Johnson & Johnson has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct a phase III clinical study of the anti-cancer drug Amivantamab.

This came after Johnson & Johnson presented phase III clinical study protocol no: 61186372COR3002 version no. original, dated 26-JUL-2024.

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.

Amivantamab, also known as JNJ-61186372, is an anti-EGFR-MET bispecific antibody, derived from Chinese hamster ovary cells, approved for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. Patients with NSCLC often develop resistance to drugs that target EGFR and MET individually, so amivantamab was developed to attack both targets, reducing the chance of resistance developing.

Mesenchymal-epithelial transition factor (MET) is a receptor with tyrosine kinase activity expressed on epithelial cells that, upon signalling, dimerizes and activates downstream pathways that signal cell division. The Epidermal Growth Factor Receptor (EGFR) is a transmembrane protein with tyrosine kinase activity that can further activate downstream pathways that signal cell division, survival, and angiogenesis. Patients with NSCLC with exon 20 insertion mutations in EGFR do not respond to tyrosine kinase inhibitors and are generally treated with platinum-based therapy. Exon 20 insertion mutations in EGFR also lead to conformational changes that activate EGFR.

At the recent SEC meeting for Oncology held on 8th and 9th October 2024, the expert panel reviewed phase III clinical study protocol no: 61186372COR3002 version no. original, dated 26-JUL-2024.

After detailed deliberation, the committee recommended a grant of permission to conduct the trial as presented by the firm.

Also Read: CDSCO prioritizes transparency, digitizes more than 95% regulatory processes