AstraZeneca Pharma India has secured approval to import and distribute Trastuzumab Deruxtecan 100mg/5mL (Enhertu) for an additional indication. The approval allows for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have previously undergone systemic treatment and have no satisfactory alternative treatment options. This approval expands the availability of Enhertu for a specific patient population in India.
Enhertu Expanded Use
AstraZeneca Pharma India Limited has received permission to import for sale and distribution of Trastuzumab Deruxtecan 100mg/5mL vial lyophilized powder concentrate for solution for infusion (Brand name: Enhertu) for an additional indication.
Target Patient Group
The approved indication specifically targets adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors. These are patients who have already received prior systemic treatment and for whom there are no satisfactory alternative treatment options available.
Implications for Marketing
This approval paves the way for the marketing of Trastuzumab Deruxtecan 100mg/5mL in India for the specified additional indication. This is subject to the receipt of related statutory approvals, if any.
Source: BSE
