7 March 2022

Background

The Scottish Medicines Consortium (SMC) has today announced its decision to recommend Trodelvy for use on the NHS in Scotland.

Sacituzumab govitecan (also called Trodelvy) is owned by Gilead and is a targeted (biological) therapy. Many triple negative breast cancer cells have a higher-than-normal level of a protein called TROP2 on their surface and Trodelvy attaches to the TROP2 proteins and can stop the cancer cells growing.

When the sacituzumab govitecan attaches to the proteins, it delivers the chemotherapy drug SN-38 directly into the breast cancer cells to destroy them. This treatment is suitable for patients with unresectable locally advanced or secondary triple negative breast cancer who have had at least two prior therapies, at least one of them given for their advanced disease (unresectable locally advanced or secondary).

The phase 3 ASCENT trial showed a significant benefit of sacituzumab govitecan (Trodelvy) when compared with chemotherapy with respect to progression free survival and overall survival. The median progression free survival was 5.6 months with sacituzumab govitecan and 1.7 months with chemotherapy. For the same population, the median overall survival was 12.1 months with sacituzumab govitecan and 6.7 months with chemotherapy.

The company estimates that approximately 150 women in Scotland each year could be eligible for this treatment.This treatment has been the focus of a Breast Cancer Now campaign, Time for Trodelvy following its licensing through the MHRA Project Orbis route. More information on this can be found here.

The NICE appraisal for Trodelvy is currently ongoing and the first committee meeting will take place on 15 March 2022, whereby a decision will follow shortly after this. 

Wales normally follow NICE decisions and Breast Cancer Now are writing to decision-makers in Northern Ireland to understand timings for a decision following the SMC news.

Responding to the news that the Scottish Medicines Consortium (SMC) has recommended Trodelvy for use on the NHS in Scotland, Baroness Delyth Morgan, Chief Executive at Breast Cancer Now, said:

“The SMC’s decision to recommend Trodelvy for use on the NHS in Scotland marks a momentous and long-awaited milestone for certain patients with incurable triple negative secondary breast cancer,* that I’m so proud Breast Cancer Now and our patient advocates were pivotal to securing.

“For far too long, people with this particularly aggressive type of incurable breast cancer have faced devastating prospects of limited treatment options and a poorer prognosis. The availability of Trodelvy is a major advance in treatment options now available to these women, that brings them hope of precious extra months to live* and do what matters most to them, from fulfilling milestones to making memories with loved ones.

“We’re delighted our tireless campaigning for Trodelvy to be made available to eligible women in the interim between licensing and a decision on its routine use on the NHS, enabled access up until today’s news, and now guarantees access for patients on the NHS in Scotland.

“However, this is not yet the case across the rest of UK,* which is why it is absolutely crucial that NICE and the drug company Gilead do everything they can to ensure that routine NHS access is made a reality for all eligible women, after the first committee meeting later this month.

“We encourage women to discuss their breast cancer treatment options with their healthcare team, and they can also speak to our expert nurses by calling our free Helpline on 0808 800 6000.”

ENDS

Notes to Editor

*unresectable locally advanced or secondary breast cancer after two prior treatments, with at least one of them being for advanced breast cancer

*compared to chemotherapy

*NICE makes decisions on the use of treatments on the NHS in England which Wales normally follows. In this instance we are expecting Northern Ireland to follow the SMC decision and we await confirmation of this.