The drug is used in breast cancer treatment.
The company, in an exchange filing, said it has received permission from the CDSCO for the drug’s 100mg/5ml lyophilized powder for concentrate for solution for infusion (brand name: Enhertu) for an additional indication.
The latest approval builds on the CDSCO’s clearance granted in June, when AstraZeneca received permission for an additional indication of Enhertu in adults with advanced HER2-positive breast cancer.
That approval allowed the therapy, in combination with pertuzumab, to be used as a first-line treatment for patients with unresectable or metastatic HER2-positive breast cancer.
Enhertu is an antibody-drug conjugate used to treat certain HER2-expressing cancers and is approved for multiple oncology indications globally. The latest clearance further expands the drug’s approved use in India, subject to any other statutory approvals, where applicable.
Last month, the company received approval from India’s drug regulator for the additional indication of this cancer therapy drug, expanding its use in patients with advanced HER2-positive breast cancer.
As per the permit, Enhertu, in combination with pertuzumab, can be used as a first-line treatment for adult patients with unresectable or metastatic HER2-positive breast cancer.In the fourth quarter, the company reported a 23% decline in net profit at ₹44.8 crore from ₹58.2 crore in the previous year.
Its revenue increased 20.4% to ₹578.6 crore from ₹480.4 crore.
The company’s EBITDA declined 29.4% to ₹60.9 crore from ₹86.2 crore, and its EBITDA margin contracted sharply to 10.5% from 17.9% in the year-ago period.
The stock ended 0.8% lower at ₹12,774 apiece following the announcement on Monday. The stock has declined 6% this year so far.
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