Johnson & Johnson Gets CDSCO Panel Okay To Study Anti-cancer Drug Lazertinib/Amivantamab
New Delhi: Pharmaceutical major Johnson and Johnson has got green signal from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization ,(CDSCO) to conduct the Phase III clinical trial of the anti cancer drug Lazertinib/Amivantamab.However this nod is subjected to the condition that study should be conducted initially in 25 subjects from India...
New Delhi: Pharmaceutical major Johnson and Johnson has got green signal from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization ,(CDSCO) to conduct the Phase III clinical trial of the anti cancer drug Lazertinib/Amivantamab.
Lazertinib is an oral, third-generation, epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) being developed by Yuhan and Janssen Biotech for the treatment of non-small cell lung cancer (NSCLC). It is a brain-penetrant, irreversible EGFR-TKI that targets the T790M mutation and activating EGFR mutations Ex19del and L858R, while sparing wild type-EGFR.
Amivantamab is an epidermal growth factor (EGF) and mesenchymal–epithelial transition (MET) receptor targeted antibody indicated in the treatment of non-small cell lung cancer with an EGFR 20 exon insertion mutation.
Amivantamab is a bispecific epidermal growth factor (EGF)receptor-directed and mesenchymal–epithelial transition (MET) receptor-directed antibody. 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.
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