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.
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