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  • CDSCO Panel grants J&J...

CDSCO Panel grants J&J Protocol Amendment proposal to study anticancer drug Amivantamab and Lazertinib

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-01-09T17:45:19+05:30  |  Updated On 22 March 2024 10:27 PM IST
USFDA nod to JnJ Tremfya for Crohns disease
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New Delhi: Regarding the study of Amivantamab and Lazertinib in combination with platinum-based chemotherapy compared with platinum-based chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated locally advanced or metastatic non- small cell lung cancer after osimertinib failure, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major Johnson and Johnson's proposal of protocol amendment 6.0 dated 22 December 2022 protocol No. 61186372NSC3002.

The purpose of this study is to assess the efficacy of adding lazertinib to amivantamab, carboplatin, and pemetrexed (LACP/ACP-L dosing strategies) and amivantamab, carboplatin, and pemetrexed (ACP) compared with carboplatin and pemetrexed (CP) in participants with locally advanced or metastatic epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R substitution non-small cell lung cancer (NSCLC) after osimertinib failure. The purpose of the extension cohort is to further describe the safety and efficacy for the ACP-L dosing schedule versus ACP with additional data.

This came after the drug major Johnson and Johnson presented protocol amendment 6.0 dated 22 December 2022 protocol No. 61186372NSC3002.

Lazertinib is an orally available third-generation, selective inhibitor of certain forms of the epidermal growth factor receptor (EGFR) with activating mutations, including the resistance mutation T790M, exon 19 deletions (Del19), and the L858R mutation, with potential antineoplastic activity. Upon administration, lazertinib specifically and irreversibly binds to and inhibits selective EGFR mutants, which prevents EGFR mutant-mediated signaling and leads to cell death in EGFR mutant-expressing tumor cells. Lazertinib may inhibit programmed cell death-1 ligand 1 (PD-L1) and inflammatory cytokines in specific cancer cells harboring certain EGFR mutations.

Amivantamab is an EGF and MET receptor-targeted antibody indicated in the treatment of non-small cell lung cancer with an EGFR 20 exon insertion mutation.

Amivantamab targets both EGFR and MET, preventing ligands from binding to the receptors, blocking signaling, marking the cancerous cells for antibody-dependant cellular cytotoxicity by natural killer cells, and allowing macrophages to perform trogocytosis.

At the recent SEC meeting for Oncology and Hematology held on 21st and 22nd December 2023, the expert panel reviewed the protocol amendment 6.0 dated 22 December 2022 protocol No. 61186372NSC3002 presented by the drug major Johnson & Johnson.

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

Also Read: Justify Durvalumab dose: CDSCO Panel Tells AstraZeneca on Study of Dato-DXd and Durvalumab

Johnson & JohnsoncdscoamivantamabLazertinibnon-small cell lung canceranticancer drug
Dr. Divya Colin
Dr. Divya Colin

    Doctor of Pharmacy

    Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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