Pfizer Gets CDSCO Panel Nod To study Anti-cancer Drug Disitamab vedotin

However, this approval is subject to the condition to include more geographically distributed government sites in the study and the principal investigator (PI) should be a medical oncologist.

This came after the firm presented phase 3 clinical study protocol no: C5731001 amendment 03 dated 03 December-2024.

Disitamab vedotin (DV, also known as RC48) is an antibody-drug conjugate (ADC) used to treat HER2-positive solid tumors, particularly gastric cancer and urothelial cancer. It consists of a monoclonal antibody targeting HER2, linked to the cytotoxic agent monomethyl auristatin E (MMAE), which is delivered to tumor cells.

Disitamab Vedotin (also known as RC48) is classified as an antibody-drug conjugate (ADC). ADCs are a type of targeted cancer therapy that combines a monoclonal antibody with a cytotoxic drug.

At the recent SEC meeting for oncology held on 11th March 2025, the expert panel reviewed phase 3 clinical study protocol no. C5731001 amendment 03 dated 03-December-2024.

After detailed deliberation, the committee recommended the grant of permission to conduct the trial as presented by the firm with the following condition:

1. More geographically distributed government sites shall be included in the study.

2. The principal investigator (PI) shall be a medical oncologist only.

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