20 April 2021

The National Institute for Health and Care Excellence (NICE) has today (20 April 2021) announced its decision to recommend breast cancer drug trastuzumab deruxtecan (Enhertu) for use on the NHS in England via the Cancer Drugs Fund. This will offer a new treatment option for patients with HER2 positive cancer that cannot be removed by surgery or secondary incurable breast cancer who have already had two or more other treatments specifically for this type of breast cancer.

Trastuzumab deruxtecan (Daiichi Sankyo) is a targeted or biological treatment which combines two drugs – a targeted drug like trastuzumab and a chemotherapy drug called deruxtecan. It works by the trastuzumab attaching itself to the HER2 proteins which can stop the cancer cells growing. When the trastuzumab attaches to the proteins, it delivers deruxtecan directly into the breast cancer cells to kill them. This treatment is given as an intravenous infusion every 3 weeks.

A phase 2 trial (DESTINY-Breast01) demonstrated a high proportion of patients’ tumours respond to trastuzumab deruxtecan (61.4%). The trial did not directly compare trastuzumab deruxtecan with any other treatments. Indirect comparisons undertaken as part of the appraisal suggest the treatment may increase the time before a patient’s diseases progresses and how long people live compared to chemotherapy. However, the data is immature and further information is required which will be collected from ongoing trials and NHS practice.

The Cancer Drugs Fund enables NICE to conditionally approve promising treatments whilst more data is collected. Following this period of data collection, NICE will reconsider the treatment and make a decision on whether it can be routinely approved for use on the NHS.

It is estimated that up to 400 people will have immediate access to trastuzumab deruxtecan in England. Wales and Northern Ireland normally follow NICE decisions. We expect the Scottish Medicines Consortium will assess the treatment for use on the NHS in Scotland this year.

Baroness Delyth Morgan, Chief Executive at Breast Cancer Now, said:

“Today’s approval of trastuzumab deruxtecan (Enhertu) is fantastic news for hundreds of patients with HER2 positive incurable secondary breast cancer who desperately need new effective targeted treatments which can delay the use of chemotherapy, its debilitating side effects and reduced quality of life.

“Crucially, this promising new targeted treatment may potentially offer patients more time before their disease progresses or may extend their lives, meaning more precious time with their loved ones, than chemotherapy brings. We look forward to further results to understand whether this new treatment could offer patients extra time to live.

“Women who’ve already had two or more targeted treatments and are fast running out of innovative options will be able to access Enhertu much sooner thanks to the Cancer Drugs Fund enabling promising treatments to reach patients on the NHS quickly while further data is collected. Upcoming proposals for the new Innovative Medicines Fund must ensure breast cancer patients continue to have quick access to potentially life-changing new drugs.

“Now, it is crucial Daiichi Sankyo and the Scottish Medicines Consortium work quickly to ensure that patients in Scotland also benefit from this exciting new drug.

“Anyone affected by breast cancer can speak to Breast Cancer Now’s expert nurses by calling our free Helpline on 0808 800 6000 for information and support.”

Claire Myerson, 51 years old from Oxfordshire, is married with two children and has been living with incurable secondary breast cancer in her bones for six years, after first being diagnosed with HER2+ primary breast cancer in 2013. For the past four years Claire has been going to the hospital every three weeks to have intravenous treatments of the targeted therapy, Kadcyla, aimed at keeping the cancer at bay. When Kadcyla stops working, trastuzumab deruxtecan (Enhertu) could now provide an additional targeted treatment option for Claire. Claire is a Breast Cancer Now campaigner and said:

“For five years now I’ve been holding out hope that I would stay alive long enough to see the introduction of new and effective treatments that could offer me the chance to keep living as well as possible and continue doing the things I love. The approval of trastuzumab deruxtecan (Enhertu) could finally make this a reality and be life-changing for patients like me.

“I know my current treatment, Kadcyla, will eventually stop working and my cancer will progress again and before today, there were no further targeted treatments for me to try offering a more tolerable level of side effects than chemotherapy, the only other option available. For me returning to chemotherapy at the end of my life is not something I will choose.

“Secondary breast cancer has impacted every aspect of my life - family, work and relationships – but I’m still here, and it’s new targeted treatments that are keeping me alive and offering me the hope that I will see my children grow into young adults, feel well enough to spend quality time with my friends and family, and make every day a special day.”