Trodelvy®▼ (sacituzumab govitecan) recommended for use on NHS in England for women with metastatic triple negative breast cancer

Trodelvy^®▼ (sacituzumab govitecan) recommended for use on NHS in England for women with metastatic triple negative breast cancer

14^th JULY 2022, LONDON, UK – Gilead Sciences, Inc. today announced that the National Institute for Health and Care Excellence (NICE) has recommended Trodelvy (sacituzumab govitecan) for use on the NHS in England within its marketing authorisation, as an option for treating unresectable triple-negative locally advanced or metastatic breast cancer in adults after two or more systemic therapies, at least one of which was for advanced disease.[i] This treatment has the potential to slow progression of the disease by several months and extend survival compared to existing therapies.

Triple-negative breast cancer (TNBC) is one of the most aggressive forms of breast cancer and there is a limited number of therapeutic options available - particularly for those whose disease has metastasised (spread from the primary site of cancer). Approximately 8,000 people are diagnosed with TNBC each year[ii] and around a third of these will experience a metastatic recurrence of their disease within a median period of 2.6 years.[iii]

Professor Christopher Twelves, Honorary Consultant in Oncology at Leeds Teaching Hospitals said: “Treating women with triple-negative breast cancer has been notoriously challenging and, once the cancer has spread, there have been few treatment options that meaningfully impact on survival. Today’s decision changes that. We now have the option to use a potent, targeted therapy that has definitively shown potential to increase survival compared with standard chemotherapy. This is not a cure, but for many women with triple-negative breast cancer it offers some vitally important extra months with their loved ones.”

The NICE appraisal was based on data from the Phase III ASCENT study of sacituzumab govitecan.[iv] This study reported significant and clinically meaningful improvements in its primary efficacy endpoint of progression-free survival (PFS); when compared to treatment with chemotherapy, median PFS (mPFS) trebled (5.6 months versus 1.7 months). Sacituzumab govitecan also demonstrated an extension in median overall survival (OS) by over 5 months when compared to standard of care (12.1 months versus 6.7 months).^iv The most frequent treatment-related adverse events of grade 3 or higher associated with sacituzumab govitecan were neutropenia (51%), leukopenia (10%), diarrhoea (10%), anaemia (8%), and febrile neutropenia (6%).[v]

Dr Véronique Walsh, Vice President and General Manager, UK & Ireland said: “At Gilead, we aim to ensure that everyone who could potentially benefit from our medicines has the chance to do so. The availability of this important treatment option for people with triple-negative breast cancer has been a key priority of ours for many months and we are delighted that Trodelvy will be routinely available to eligible patients on the NHS in England and Wales. We are grateful for the efforts of the entire breast cancer community that stressed the urgency of this decision and supported the process.”

This treatment was made available by the Scottish Medicines Consortium for use on the NHS in Scotland in March 2022 and Wales will now implement the NICE guidance.

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^[i] NICE. Sacituzumab govitecan for treating unresectable locally advanced or metastatic triple-negative breast cancer after 2 or more therapies [ID3942].

[ii] Breast Cancer Now. Triple negative breast cancer explained. Available at: https://breastcancernow.org/about-us/news-personal-stories/triple-negative-breast-cancer-explained. Last accessed: July 2022.

[iii] Kassam F et al. Survival Outcomes for Patients with Metastatic Triple-Negative Breast Cancer: Implications for Clinical Practice and Trial Design. Clinical Breast Cancer. 2009;9(1):29-33. https://doi.org/10.3816/CBC.2009.n.005.

[iv] Trodelvy Summary of Product Characteristics.

[v] Bardia et al. Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer. 2021; 384(16):1529-1541. https://doi.org/10.1056/NEJMoa2028485.