The Scottish Medicines Consortium (SMC) has approved today:

  • Trastuzumab deruxtecan (Enhertu) for treating HER2-positive unresectable or metastatic breast cancer in adults who have received two or more prior anti-HER2 based therapies for routine use on the NHS in Scotland.The license is on an interim basis.
  • Tucatinib (Tukysa) with trastuzumab and capecitabine for treating HER2-positive locally advanced or metastatic breast cancer after two or more anti-HER2 therapies for routine use on the NHS in Scotland.

METUPUK are delighted by the Scottish Medicines Consortium (SMC) approval of both Trastuzumab Deruxtecan AND Tucatinib (with trastuzumab and capecitabine) for routine use on the NHS and the approval of trastuzamab deruxtecan on an interim basis subject to ongoing evaluation. 

Jo Taylor, founder of METUPUK, commented:

“These two drug authorisations are a significant step forward for the many Scottish patients living with HER2-positive metastatic breast cancer. We know up to 50% of patients with metastatic HER2 positive breast cancer go on to develop brain metastases.  Today a treatment combination has been made available to Scottish NHS patients that is proven to show increased overall survival in patients with brain metastases.  Disease progression in metastatic breast cancer patients is an unmet need beyond second line treatment and new medicines are essential in the challenge to supress this incurable disease.”  

Lesley Stephen is an advocate for METUPUK and lives in Scotland.  She submitted evidence to the SMC on behalf of METUPUK and commented: 

“This is a significant milestone for the people in Scotland living with HER2-positive metastatic breast cancer.  There is a significant unmet need within metastatic breast cancer and new treatment options are important in tackling the disease burden.”

Approval of two additional lines of anti-HER2 therapy means patients in Scotland will gain extra time to spend with their loved ones.  It will help bridge some of the gap in drug access between NHS patients and patients in other similar income countries who already are offered anti-HER2 therapy beyond two lines of treatment.  

We also call on NICE to approve both trastuzumab deruxtecan and Tucatinib (with trastuzumab and capecitabine) in England and subsequently in Wales and Northern Ireland once the NICE guidance is published.  All patients across the UK who could benefit from these treatments should be able access them.  The UK is a high income country, a member of the G7 and should fund cancer treatments that patients in other high income counties can access.  Restrictive drug access contributes to UK cancer survival comparing poorly to similar income countries.

Improved drug access allows us to stay #BusyLivingWithMets and increase our survival outcomes.

We demand change.  


Additional notes:

Tucatinib (Tukysa, manufactured by Seagen Inc) is an oral Tyrosine Kinase Inhibitor (TKI) for HER2 positive locally advanced or metastatic patients.  Tucatinib has been granted a Promising Innovative Medicine (PIM) Designation by the Medicines and Healthcare products Regulatory Agency (MHRA).

Results from the HER2CLIMB trial showed significant increases in overall survival and progression free survival in patients in the Tucatinib arm compared to placebo.  Patients with active and progressing brain metastases were included in this trial meaning the study group was similar to the general patient population.  Tucatinib is the first drug to show increased overall survival in patients with brain metastases in a randomised control trial, making this a step-change drug.  Up to 50% of patients with HER2-positive metastatic cancer go on to develop brain metastases, so Tucatinib addresses an unmet need.

Trastuzumab deruxtecan (Enhertu, manufactured by Daiichi Sankyo UK and AstraZeneca UK)

is a HER2 directed antibody drug conjugate (ADC). ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy (‘payload’) to cancer cells.

The recommendation is based on the phase 2 DESTINY-Breast01 trial of trastuzumab deruxtecan in patients with HER2 positive metastatic breast cancer who had received two or more prior anti-HER2-based therapies. Results from the data cut-off in June 2020 demonstrated a confirmed objective response rate (ORR).