AstraZeneca Gets CDSCO Panel Nod for Enhertu 100mg for additional indication of breast cancer
New Delhi: Noting an unmet medical need in the country, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved AstraZeneca's Trastuzumab deruxtecan concentrate solution for infusion 100mg (Enhertu 100mg) for the treatment of adult patients with unresectable or metastatic HER2-Low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.
This came after the firm presented the proposal for approval of additional indication for Trastuzumab Deruxtecan Powder for Concentrate for Solution for Infusion(Enhertu 100mg) i.e. “for the treatment of adult patients with unresectable or metastatic HER2-Low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy."
The firm continued that the proposal is for patients with hormone receptor-positive (HR+) breast cancer who should additionally have received or be ineligible for endocrine therapy under the category of life-threatening and unmet needs in the country.
In addition to the above, the firm requested for a waiver of the local clinical trial.
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. After 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, deruxtecan (DXd) causes targeted DNA damage and apoptosis in cancer cells, due to the ability to cross cell membranes.
In the recent SEC meeting for oncology and hematology held on 7th and 8th December 2023, the firm presented the results of clinical studies conducted in other countries.
The committee noted that the proposed indication of the drug is approved in other countries including the US, EU, and Canada and there is unmet medical need in the country for the proposed indication.
After detailed deliberation, the committee recommended the approval of the proposed additional indication with a local clinical trial waiver.
