Trodelvy®▼ (sacituzumab govitecan) accepted for NHS use in Scotland for women with metastatic triple negative breast cancer

Trodelvy^®▼ (sacituzumab govitecan) accepted for NHS use in Scotland for women with metastatic triple negative breast cancer

7 March 2022, LONDON, UK – Gilead Sciences, Inc. today announced that the Scottish Medicines Consortium (SMC) has accepted Trodelvy (sacituzumab govitecan) for use on the NHS in Scotland for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior lines of systemic therapies, at least one of them given for unresectable locally advanced or metastatic disease.[i] This decision means approximately 150 women in Scotland each year could be eligible for this treatment, which has the potential to extend their lives by several months and slow progression of their disease, compared to existing therapies. This is the first therapy specifically recommended for the treatment of mTNBC that has relapsed after prior systemic therapy.

Dr Caroline Michie, Honorary Clinical Senior Lecturer at University of Edinburgh said: “Today’s approval will be the most welcome of news for patients with triple negative breast cancer. There is a huge unmet need for more effective drugs in this type of secondary breast cancer, and this will represent the first new medicine approval after first line treatment in over a decade. Patients with this form of the disease unfortunately are often younger, and, for them, having hope is everything. I know many patients of mine have been anxiously awaiting this decision and will be hugely relieved and delighted today. I would also like to commend the SMC for bringing forward this review, acknowledging the real unmet need to increase the number of treatment options for patients as quickly as possible.”

The decision to accept sacituzumab govitecan for use on the NHS was based on data from the Phase III ASCENT study,i which reported significant and clinically meaningful improvements in its primary efficacy endpoint of progression-free survival (PFS). In the trial, median PFS (mPFS) trebled when compared to treatment with chemotherapy (5.6 months versus 1.7 months). Additionally, the treatment demonstrated an extension in median overall survival (OS) by over 5 months compared to chemotherapy (12.1 months versus 6.7 months). The most common serious adverse reactions (incidence of ≥3%) were febrile neutropenia (4.5%), diarrhoea (3.8%) and pneumonia (3%).i

TNBC is a specific type of breast cancer. Traditionally, breast cancer therapies work by targeting either hormone receptors (HR) or human epidermal growth factor receptor 2 (HER2).[ii] However, in TNBC none of these traditional receptors are present on cancer cells. This means that TNBC can be a particularly difficult cancer to treat. The metastatic stage of the disease is when the disease has spread and is typically considered incurable.

Around 4,700 women are diagnosed with breast cancer in Scotland each year[iii] – an estimated 11-15% of these cases are triple-negative. Around a third of all people diagnosed with TNBC will experience a metastatic recurrence of their disease within a mean period of 2.6 years.[iv]

Dr Véronique Walsh, Vice President and General Manager, UK & Ireland said: “At Gilead, our priority is to ensure that everyone who could potentially benefit from our treatments and innovations has the chance to do so. Today’s decision from the SMC is a key step in that journey and we are delighted that this much needed treatment option will now be routinely available to eligible NHS patients across Scotland. We remain mindful that there are many other women across the UK in need of the same reassurance and we are continuing to work closely with all relevant parties to make Trodelvy available as quickly as possible.”

Sacituzumab govitecan is currently undergoing a health technology appraisal (HTA) with the National Institute for Health and Care Excellence (NICE) to determine its use on the NHS in England. A decision from NICE is expected in 2022. It is expected that Northern Ireland will align to the SMC’s decision and make a decision on making sacituzumab govitecan available on the health service within several months; Wales will follow the guidance provided by NICE. Gilead are supporting access to patients elsewhere in the UK through a free-of-charge pre-reimbursement access scheme to enable broader and more equitable access prior to routine reimbursement.

References

[i] Trodelvy Summary of Product Characteristics.

[ii] American Cancer Society. Triple-negative Breast Cancer. Available at: https://www.cancer.org/cancer/breast-cancer/understanding-a-breast-cancer-diagnosis/types-of-breast-cancer/triple-negative.html.

[iii] Glasgow researchers to investigate using existing drug as new treatment for triple negative breast cancer. Breast Cancer Now. Available at: https://breastcancernow.org/about-us/media/press-releases/glasgow-researchers-investigate-using-existing-drug-new-treatment-triple-negative-breast-cancer.

[iv] Dent, R, et al. Triple-Negative Breast Cancer: Clinical Features and Patterns of Recurrence. Clinical Cancer Research. 2007. 13(15), 4429-4434.