JnJ cancer drug Amivantamab gets CDSCO panel okay with waiver of local phase 3,4 trials
New Delhi: Considering an unmet medical need in the country, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has given its nod to global pharmaceuticals major Johnson and Johnson (JnJ) to import and market the monoclonal antibody medication Amivantamab, which is used to treat non-small cell lung cancer.
This came after the drug-maker Johnson and Johnson presented the proposal for import and marketing of Amivantamab in the country along with the results of various clinical trials conducted overseas with a request for waiver of Phase-III and Phase-IV clinical trials in the country.
Amivantamab is a bispecific epidermal growth factor (EGF) receptor-directed and mesenchymal–epithelial transition (MET) receptor-directed antibody which is derived from Chinese hamster ovary cells.
It is 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.
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