Submit safety, efficacy data of Indian Patients: CDSCO Panel Tells AstraZeneca on additional indication of Enhertu 100mg
Written By : Dr. Divya Colin
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2023-12-29 12:45 GMT | Update On 2024-03-22 17:15 GMT
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New Delhi: In response to the drug major AstraZeneca's proposal for the additional indication of Trastuzumab Deruxtecan Powder Concentrate Solution for Infusion (Enhertu 100mg) to treat adult patients with unresectable or metastatic Non-small cell lung cancer (NSCLC) whose tumors have activated HER2 (ERBB2) mutations and who have received prior systemic therapy, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended the firm to submit the safety and efficacy data of Indian Patients for the proposed indication.
This came after the firm presented the proposal for the addition of indication for Trastuzumab Deruxtecan Powder for Concentrate for Solution for Infusion (Enhertu 100mg) under the category of life-threatening and unmet need in the country with the request for the waiver of the local clinical trial.
The proposed additional indication is “for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations and who have received prior systemic therapy.”
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