AstraZeneca Pharma India Receives Permission for Trastuzumab Deruxtecan Sale and Distribution in India for Additional Indications
AstraZeneca Pharma India Limited announced the receipt of permission from the Central Drugs Standard Control Organisation, Directorate General of Health Services, Government of India, to import, sell, and distribute Trastuzumab deruxtecan lyophilized powder for concentrate for solution for infusion 100mg (Enhertu) for the treatment of HER2-Low metastatic breast cancer and HER2-positive locally advanced or metastatic gastric cancer in India. This approval follows previous success in the metastatic setting or recurrence during or within 6 months of completing adjuvant chemotherapy for breast cancer patients and after receiving a prior trastuzumab-based regimen in the case of gastric cancer patients. The launch of Trastuzumab deruxtecan in India for these additional indications is subject to the receipt of related statutory approvals.
Key Highlights
- AstraZeneca Pharma India receives permission to import, sell, and distribute Trastuzumab deruxtecan for additional indications
- Drug indicated for HER2-Low metastatic breast cancer and HER2-positive locally advanced or metastatic gastric cancer
- Permitted for use after failure of prior chemotherapy in the breast cancer metastatic setting or adjuvant chemotherapy recurrence
- Approved for patients with locally advanced or metastatic gastric cancer who have received a prior trastuzumab-based regimen