The company said it received permission from the Central Drugs Standard Control Organisation (CDSCO) on June 10 to import and market Trastuzumab deruxtecan 100 mg/5 mL vial lyophilised powder for concentrate for solution for infusion under the brand name Enhertu for the new indication.
Under the approval, Enhertu, in combination with pertuzumab, can now be used as a first-line treatment for adult patients with unresectable or metastatic HER2-positive breast cancer, including those identified as IHC3+ or ISH+.
The approval expands the eligible patient population for the therapy in India and allows AstraZeneca to market the drug for the additional indication, subject to any other required statutory clearances.
Enhertu is an antibody-drug conjugate developed for the treatment of certain HER2-expressing cancers and is already approved for multiple oncology indications globally.
For the March quarter, the pharma company reported a 23% year-on-year fall in net profit to ₹44.8 crore from ₹58.2 crore in the same quarter last year. Revenue grew 20.4% Year-on-Year to ₹578.6 crore from ₹480.4 crore last year. Earnings Before Interest, Tax, Depreciation, and Amortisation, dropped 29.4% to ₹60.9 crore from ₹86.2 crore a year ago, while EBITDA margin also contracted to 10.5% from 17.9%.
For FY26, the company reported total revenue of ₹2,275.6 crore, driven by sustained growth in Oncology and Biopharmaceuticals, and progress in the Rare Disease segment.
After the initial spike seen post the announcement, during which the stock made an intraday high of ₹8,409, AstraZeneca Pharma India’s shares are now trading little changed at ₹8,292. The stock is still down 5.5% so far this year.
