Submit Clinical Data in Indian Subjects: CDSCO Panel Tells AstraZeneca on Trastuzumab deruxtecan
New Delhi: Responding to the proposal presented by AstraZeneca Pharma India for the approval of additional indication of the drug Trastuzumab Deruxtecan 100 mg powder for concentrate for solution for infusion, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has stated the firm to submit the clinical data in Indian subjects of the proposed drug for the applied additional indication.
This came after AstraZeneca Pharma India presented the proposal for the approval of additional indication of the drug Trastuzumab Deruxtecan 100 mg powder for concentrate for solution for infusion, i.e., for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior treatment or who have no satisfactory alternative treatment options under unmet need in the country.
The committee noted that the firm has obtained accelerated approval in the US for the proposed additional indication based on the Phase II study. Further, it was noted that there is no clinical data available in Indian subjects for the applied additional indication.
Trastuzumab deruxtecan is a targeted drug used to treat certain types of cancer: breast cancer, gastric or gastroesophageal adenocarcinoma, advanced solid cancers with high levels of HER2, advanced lung cancer, and advanced colorectal cancer.
Trastuzumab deruxtecan is an antibody-drug conjugate (ADC) that works by attaching to the HER2 protein on cancer cells and delivering a chemotherapy payload to kill them.
Trastuzumab is a monoclonal antibody that attaches to HER2 and activates the immune system to kill cancer cells. Deruxtecan is a chemotherapy drug that enters cancer cells and blocks topoisomerase I, an enzyme needed to copy cell DNA
At the recent SEC meeting for Oncology held on 12th November 2024, the expert panel reviewed the proposal for the approval of additional indication of the drug Trastuzumab Deruxtecan 100 mg powder for concentrate for solution for infusion, i.e., for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior treatment or who have no satisfactory alternative treatment options under unmet need in the country.
After detailed deliberation, the committee recommended submitting the clinical data in Indian subjects for the applied additional indication.
