Johnson & Johnson Gets CDSCO Panel Okay To Study Anti-cancer Drug Lazertinib/Amivantamab

Published On 2022-11-04 12:30 GMT | Update On 2022-11-04 12:30 GMT

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 and applicant should submit their data for review by the committee for further continuation of the trial.

Furthermore, it is stated that death irrespective of its cause i.e. PD should be considered as Serious Adverse Event (SAE) and same to be reported to the CDSCO as per provisions of the New Drugs and Clinical Trial Rules, 2019 during the trial.

This came after the firm presented Phase III clinical trial protocol no. 61186372NSC3004 (PALOMA 3) before the committee.

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.

At the recent SEC meeting for Oncology and Hematology held on October 19th 2022, the expert panel reviewed the Phase III clinical trial protocol of anti cancer drug Lazertinib/Amivantamab Regime presented by Johnson and Johnson.

After detailed deliberation, the committee recommended the grant of permission to conduct the study with following conditions-

1.The study should be conducted initially in 25 subjects from India and applicant should submit their data for review by the committee for further continuation of the trial.

2. Death irrespective of its cause i.e. PD should be considered as SAE and same to be reported to the CDSCO as per provisions of the New Drugs and Clinical Trial Rules, 2019 during the trial.

Accordingly, the expert panel directed that the firm should submit protocol addendum for the same to CDSCO

Also Read:Lupin Ranibizumab intravitreal injection gets CDSCO Panel nod for Phase IV study

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Dr. Divya Colin

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.

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Johnson & Johnson Gets CDSCO Panel Okay To Study Anti-cancer Drug Lazertinib/Amivantamab

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