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.
It is the first treatment for adults with non-small cell lung cancer whose tumors have specific types of genetic mutations: epidermal growth factor receptor (EGFR) exon 20 insertion mutations.
The proposal presented by Johnson & Johnson was extensively evaluated by the committee at the most recent SEC meeting for Oncology & Hematology, which was conducted on 06.08.2021 and 10.08.2021.
In line with the presented proposal, the committee observed that the proposed drug is an orphan drug and there is an unmet medical need in the country. The committee also noted that the drug is approved in the US and Europe.
In May 2021, Amivantamab received FDA approval for medicinal use in the United States.
After detailed deliberation, the committee recommended the grant of permission to import and market the drug with a waiver of local Phase III & IV clinical trials in the country.
