Submit safety, efficacy data of Indian Patients: CDSCO Panel Tells AstraZeneca on additional indication of Enhertu 100mg

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.”

Trastuzumab is a monoclonal antibody against human epidermal growth factor receptor 2 (HER2). Trastuzumab binds to an extracellular domain of this receptor and inhibits HER2 homodimerization, thereby preventing HER2-mediated signaling.

Trastuzumab is a biologic agent primarily used in the treatment of HER2-positive breast cancer. It may be used as adjuvant therapy for localized disease or as first-line therapy for metastatic disease.

Trastuzumab deruxtecan binds to HER2 found on malignant cells, it is internalized and linker cleavage occurs through the actions of lysosomal enzymes. After it is released through cleavage, DXd causes targeted DNA damage and apoptosis in cancer cells, due to the ability to cross cell membranes.

At the recent SEC meeting for Oncology and Hematology held on the 7th and 8th of December 2023, the expert panel reviewed the proposal presented by the drug major AstraZeneca for the addition of indication for Trastuzumab Deruxtecan Powder for Concentrate for Solution for Infusion (Enhertu 100mg).

The committee noted that India is part of an ongoing Phase III global clinical trial.
After detailed deliberation, the committee recommended that the firm should submit the safety and efficacy data of Indian patients for the proposed indication before the committee for consideration of the additional indication.
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