Submit Full Adverse Event Data from Lenvatinib Phase IV Liver Cancer Trial: CDSCO Panel To Eisai Pharma
New Delhi: In a recent regulatory review, the Subject Expert Committee (SEC) under the Oncology division of the Central Drugs Standard Control Organization (CDSCO) has asked Eisai Pharmaceuticals India Private Limited to submit complete safety data from its ongoing Phase IV clinical trial of Lenvatinib Capsules (4 mg and 10 mg) in patients with unresectable hepatocellular carcinoma (HCC).
The matter was taken up during the SEC (Oncology) meeting based on the company’s submission under application number SND/CT/19/000043. The firm presented the report of the Phase IV clinical trial conducted in Indian patients with unresectable HCC using Lenvatinib Capsules.
During the meeting, the committee noted that adverse events were reported during the course of the study. However, the firm did not present the complete details of these adverse events or provide any corresponding assessment reports explaining causality, severity, or resolution.
After detailed deliberation, the SEC recommended that Eisai Pharmaceuticals must submit the complete adverse event data and corresponding assessment reports related to the Phase IV study to CDSCO. These submissions will be required for further regulatory review and to determine the safety profile of the drug in the post-marketing setting.
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