AstraZeneca Pharma India Ltd. received approval from India's drug regulator on June 10 for an additional indication of its cancer therapy Enhertu. According to reports from CNBC TV18 and The Economic Times, the company received permission from the Central Drugs Standard Control Organisation (CDSCO) 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. 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.
Under the new 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+. As reported by CNBC TV18 and The Economic Times, Enhertu is an antibody-drug conjugate developed for the treatment of certain HER2-expressing cancers and is already approved for multiple oncology indications globally. The expanded indication significantly broadens the therapeutic options for breast cancer patients in India. HER2-positive breast cancer is a subtype where tumor cells overexpress the HER2 protein, which is generally considered faster-growing than other types. In about one of every 5 breast cancer patients, the cancer cells have extra copies of the gene that makes the HER2 protein, accounting for a significant proportion of breast cancer cases globally.
For the March quarter, the pharma company reported mixed financial results with net profit declining 23% year-on-year to ₹44.8 crore from ₹58.2 crore in the same quarter last year. According to CNBC TV18, revenue grew 20.4% year-on-year to ₹578.6 crore from ₹480.4 crore last year. Earnings Before Interest, Tax, Depreciation, and Amortisation (EBITDA) 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.
Following the regulatory announcement, AstraZeneca Pharma India shares gained on Thursday, June 11, with the stock making an intraday high of ₹8,409 after the initial spike. As reported by CNBC TV18 and The Economic Times, the shares are now trading little changed at ₹8,292. Despite the positive regulatory development, the stock remains down 5.5% so far this year, reflecting broader market challenges facing the pharmaceutical sector. According to latest reports, AstraZeneca shares were trading almost flat at ₹8,312.00 apiece on the BSE as of 11:33 AM on Thursday, indicating the market's measured response to the regulatory approval.
