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New Approval for Hard-to-Treat HER2-Positive Cancer Tumors

April 17, 2025

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the use of trastuzumab deruxtecan (Enhertu) for treatment of people with HER-2 positive cancers that has metastasized to other parts of the body or can not be surgically removed. Leaving them with no other treatment options on hand.

This new approval builds on the existing indications for (Enhertu), which is already authorized in certain cases of HER2-positive breast cancer, HER2-mutant non-small cell lung cancer, and HER2-positive gastric cancer.

The decision was made as part of Project Orbis, a global initiative led by the US FDA and involving international regulatory agencies from Australia, Canada, Singapore, Switzerland, Brazil, and Israel. The program aims to speed up access to promising cancer treatments worldwide.

The MHRA is always keen on providing safe & effective solutions for patients everywhere, hence trastuzumab deruxtecan (Enhertu) new indication approval will be closely monitored & anyone experiencing any side effects is encouraged to consult a doctor & report it directly to the yellow card scheme.

Learn more: Trastuzumab deruxtecan approved to treat adults with HER2-positive cancer that has spread or cannot be removed by surgery  - GOV.UK

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