AstraZeneca Receives Indian Approval for Enhertu®, Expanding Indications for HER2-Positive Breast Cancer Treatment
AstraZeneca Pharma India Limited has secured crucial governmental permission to import and distribute its specialized oncology medication, Trastuzumab deruxtecan, under the brand name Enhertu®. The approval was granted by the Central Drugs Standard Control Organization, Directorate General of Health Services, Government of India.This significant authorization allows for the marketing of Enhertu® in India for an expanded indication related to breast cancer treatment. The permission relates to the product formulation: Trastuzumab deruxtecan 100 mg/5mL vial lyophilized powder for concentrate for solution for infusion.
The approval opens up a new avenue for oncology patients, as it encompasses the use of Trastuzumab deruxtecan in combination with pertuzumab. This combination is specifically indicated for addressing the first-line treatment of adult patients diagnosed with unresectable or metastatic HER2-positive (IHC3+ or ISH+) breast cancer.
The receipt of this permission paves the way for AstraZeneca Pharma India Limited to market Enhertu® in India for this specified additional indication, subject to the fulfillment of any related statutory requirements.
Key details regarding the product and the newly authorized use are summarized below:
| Product Details | Specification/Brand Name |
|---|---|
| Active Substance | Trastuzumab deruxtecan 100 mg/5mL vial lyophilized powder for concentrate for solution for infusion |
| Brand Name | Enhertu® |
| New Indication Scope | First-line treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+ or ISH+) breast cancer |
| Combination Therapy | Trastuzumab deruxtecan in combination with pertuzumab |
ASTRAZEN Stock Price Movement
As of 10:58 AM, shares of AstraZeneca Pharma India Limited are edging higher, gaining 0.98% and reaching ₹8370 as the live market continues trading. The stock has seen significant intraday movement, currently holding within a range spanning from ₹8210.5 to ₹8399.Disclaimer: Due care and diligence have been taken in compiling and presenting news and market-related content. However, errors or omissions may arise despite such efforts.
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