7 May 2020

The National Institute for Health and Care Excellence (NICE) has today (7 May 2020) approved trastuzumab emtansine (Kadcyla) for routine NHS use for certain patients with HER2 positive primary breast cancer after their surgery.

Kadcyla (Roche) is a targeted treatment for HER2 positive breast cancer. It consists of an antibody (trastuzumab) that attaches to HER2 proteins on the surface of cancer cells and releases a dose of chemotherapy (emtansine) directly into the cells, leaving normal cells relatively unharmed.

Previously approved by NICE in 2017 as a treatment for HER2 positive secondary breast cancer, Kadcyla will now provide a new option for patients with primary breast cancer who have residual invasive disease [in the breast or lymph nodes] after neoadjuvant treatment and surgery.1

The KATHERINE clinical trial demonstrated that for patients with residual disease after neoadjuvant therapy, 88.3% treated with adjuvant Kadcyla after their surgery were free of invasive disease after three years, compared to 77% of patients treated with trastuzumab.

It is estimated that around 800 people each year in England will be eligible for treatment with Kadcyla following surgery.

Baroness Delyth Morgan, Chief Executive at Breast Cancer Now, the research and care charity, said: 

“It is wonderful news that hundreds of patients with primary breast cancer will now have an additional option to help further reduce the risk of the disease coming back.

“The fear of breast cancer returning or spreading to other parts of their body can cause significant anxiety for many women, and it’s really exciting that Kadcyla will now provide a new option for patients who haven’t fully responded to neoadjuvant therapy.

“Continued advances like Kadcyla in treating breast cancer and reducing the risk of recurrence are absolutely vital to reaching our vision that by 2050, everyone who develops breast cancer will live – and live well.

“With some cancer treatments currently being delayed or changed due to the coronavirus outbreak, it is important that the option of Kadcyla, and its risks and benefits at this time, is discussed with any eligible patients. The decision to start adjuvant Kadcyla must be made collaboratively with patients, doctors and multidisciplinary teams to ensure the right choice for each person, and it’s vital everyone has the information and support they need.

“Anyone worried about the impact of the outbreak on their breast cancer treatment options can call our free Helpline on 0808 800 6000 and speak to our expert nurses.”


Notes to Editors

Wales and Northern Ireland will usually follow decisions made by NICE, and the Scottish Medicines Consortium is expected to assess adjuvant Kadcyla for routine use in Scotland later this year.

1. Neoadjuvant treatment aims to reduce the size of the tumour before surgery. It is estimated that 40-60% of patients do not respond completely to neoadjuvant treatment, which can lead to some cancer cells remaining after surgery.