CDSCO Panel Approves Johnson and Johnson's Protocol Amendment Proposal to study anti-cancer drug Amivantamab
Written By : Dr. Divya Colin
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-07-14 12:00 GMT | Update On 2024-07-14 12:00 GMT
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New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved the drug major Johnson and Johnson's protocol amendment proposal to study the anti-cancer drug Amivantamab (JNJ-61186372) with the condition that an interim analysis report before the LTE (long-term extension) phase shall be submitted to CDSCO.
This came after the firm presented protocol amendment 3 dated 07 August 2023, protocol no. 61186372NSC3001. This is a randomized, open-label phase 3 study of combination Amivantamab and Carboplatin-Pemetrexed therapy, compared with carboplatin-pemetrexed, in patients with EGFR Exon 20ins-mutated locally advanced or metastatic non-small cell lung cancer.
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