CDSCO Panel Approves J&J's Protocol Amendment Proposal For Amivantamab, Lazertinib combination

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).

Amivantamab is used alone or with other drugs to treat adults with non-small cell lung cancer that has spread and has an abnormal EGFR gene. It is used in patients whose cancer has not been treated with other anticancer therapy or has gotten worse during or after platinum chemotherapy.

The synergistic mechanisms of action of amivantamab, which targets the extracellular ligand binding domain, combined with lazertinib, which targets the intracellular active site, have the potential to more potently inhibit the EGFR pathway than either agent alone.

Lazertinib is a potent, central nervous system (CNS) active, mutation-selective, third-generation TKI that targets T790M and sensitizing mutations while sparing wild-type EGFR. Preclinical studies demonstrated several potential differentiators of lazertinib over osimertinib.

At the recent SEC meeting for Oncology held on 5th March 2024, the expert panel reviewed the protocol amendment proposal presented by the drug major J&J.

After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm.

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