CDSCO Panel Approves J&J's Protocol Amendment Proposal For Amivantamab, Lazertinib combination
Written By : Dr. Divya Colin
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-04-14 12:00 GMT | Update On 2024-04-14 12:00 GMT
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New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major Johnson & Johnson's proposal for the protocol amendment of the fixed-dose combination ( FDC) anti-cancer drug Amivantamab Plus Lazertinib.
This came after the firm presented protocol amendment 4 dated 14 November 2023 protocol No.73841937NSC3003. The purpose of this study is to assess the efficacy of the amivantamab and lazertinib combination, compared with osimertinib, in participants with epidermal growth factor receptor (EGFR) mutation (Exon 19 deletions [Exon 19del] or Exon 21 L858R substitution) positive, locally advanced or metastatic non-small cell lung cancer (NSCLC).
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