The approval was granted by the Central Drugs Standard Control Organization (CDSCO), under the Directorate General of Health Services, Ministry of Health & Family Welfare, Govt. of India on June 10, the company said in information to the exchanges.
This further allows the use of Enhertu (Trastuzumab deruxtecan 100 mg/5mL) to be used, in combination with pertuzumab, as a first-line treatment for adults with unresectable or metastatic HER2-positive (IHC3+ or ISH+) breast cancer.
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HER2-positive breast cancer is a subtype where tumor cells overexpress the HER2 protein. It is generally considered faster-growing than the other types. In about 1 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. But, treatments that specifically target HER2 are considered effective. Therefore, this move is expected to strengthen the available treatment options to oncologists and patients alike.
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AstraZeneca shares were trading almost flat at Rs 8312.00 apiece on the BSE as of 11.33 AM on Thursday.