In a landmark decision for cancer care, the Medicines and Healthcare Products Regulatory Agency (MHRA) has approved trastuzumab deruxtecan—marketed as Enhertu—for a groundbreaking new use in the UK. The drug is now authorised for adults with unresectable or metastatic solid tumours that exhibit HER2 mutations, after exhausting other treatment options.
This marks a major expansion of the drug’s application, offering new hope to patients facing aggressive and treatment-resistant cancers.
What Is Enhertu and Who Can Benefit?
Previously available for specific HER2-positive cancers—including breast, non-small cell lung, and gastric cancers—Enhertu can now be prescribed for a wider range of HER2-positive tumours that are either inoperable or have spread to other parts of the body.
This new approval applies to patients who have no remaining standard treatment options, making it a critical option for those with limited hope.
Dr June Raine, Chief Executive of the MHRA, said: “Today’s approval marks a significant moment in personalised cancer care. Enhertu’s expanded use has the potential to improve and extend lives where other treatments have failed.”
How the Treatment Works
Enhertu is a targeted antibody-drug conjugate, combining trastuzumab, a monoclonal antibody, with a chemotherapy agent, deruxtecan. The drug delivers a powerful dose of chemotherapy directly to HER2-positive cancer cells, minimising damage to healthy tissue.
This targeted approach is part of a broader shift toward precision medicine, which aims to tailor treatments to individual genetic and molecular profiles.
Approved Through Project Orbis
The MHRA’s decision is part of Project Orbis, an international collaboration led by the US Food and Drug Administration (FDA). Other partner agencies include regulatory bodies from Australia, Canada, Switzerland, Singapore, Brazil, and Israel. The programme aims to fast-track the approval of innovative cancer treatments across multiple countries without compromising safety standards.
According to the FDA, Project Orbis has shortened drug approval timelines by months, accelerating patient access to critical therapies.
Public Reaction and Safety Measures
News of the approval has sparked cautious optimism across patient communities and social media. On Facebook, one user commented, “This gives people real hope. I just pray the side effects are manageable.” Another added, “It’s about time more personalised treatments became the norm.”
The MHRA has reminded patients and healthcare professionals to report any side effects through the Yellow Card scheme, available at yellowcard.mhra.gov.uk.
Expert Insight and Clinical Impact
A recent study published in The Lancet Oncology found that Enhertu achieved tumour response rates above 50% in some patients with HER2-positive solid tumours, suggesting strong potential across multiple cancer types.
“This approval represents both a scientific and humanitarian win,” said Dr Nadia Choudhury, an oncologist at London’s Royal Marsden Hospital. “It allows us to reach more patients with targeted therapy that could extend both lifespan and quality of life.”
What Happens Next?
- Doctors are being encouraged to review patients who may now be eligible for Enhertu under the new approval.
- Patients are advised to speak with their cancer teams about whether this treatment is right for them.
- Resources, including the NHS and Cancer Research UK websites, offer guidance for those seeking more information.
The Bigger Picture
The UK’s approval of Enhertu aligns with a global shift in oncology toward personalised and precision medicine. A report by healthcare analytics firm IQVIA noted that HER2-targeted therapies are among the fastest-growing segments in cancer treatment.
This latest decision places the UK at the forefront of that transformation, solidifying its position as a leader in innovative cancer care.
