30 July 2021
Celebrities including Jonathan Ross, Derren Brown, David Baddiel, Andy Nyman and Jane Devonshire have backed charity Breast Cancer Now’s urgent petition calling on pharmaceutical company, Gilead, to provide free-of-charge access to promising new treatment Trodelvy1 (sacituzumab govitecan) for eligible patients with triple negative incurable secondary breast cancer.
Since the petition launched on Sunday 18 July, over 85,000 people have signed up to support the calls for women living with the life-limiting disease to be given access to Trodelvy as soon as the drug is licensed, ahead of a decision being made around its routine use on the NHS next year, to guarantee it quickly reaches those who so desperately need it and don’t have time to wait.2
Women living with triple negative secondary breast cancer face the prospect of short prognoses and limited treatment options but Trodelvy could offer hundreds, in England alone, hope of precious extra months with loved ones and to do things that matter most to them.3, 4
Sophie Abbott, (57, from London) has been living with triple negative secondary breast cancer for four years. She and her husband, actor Andy Nyman, have been sharing the ‘It’s Time for Trodelvy’ petition encouraging others to add their names, and since then the petition has been shared by numerous celebrities.
Sophie was first diagnosed with triple negative breast cancer eleven years ago. Six years later after ongoing leg and back pain and six months of being misdiagnosed she found out that the breast cancer had spread to her spine and was incurable. Sophie has had numerous treatments and is currently taking denosumab and is on a body strengthening break from chemotherapy before starting a new treatment. She said:
“You feel so helpless living with a secondary breast cancer diagnosis. There's always the worry that it will spread to your vital organs. This new treatment, Trodelvy, offers a very real glimmer of hope and it's crucial that it reaches the patients who need it - it truly has the potential to prolong people’s lives. It is awful to know there are people who will die whilst they wait for access to Trodelvy. Knowing Trodelvy was available would mean I was being offered a potential reprieve from this triple negative secondary breast cancer death sentence.”
With Trodelvy’s licensing expected shortly, Breast Cancer Now is urging people to join them and sign the ‘It’s Time for Trodelvy’ petition without delay, to call on Gilead to work with NHS England and ensure that an agreement is reached in time to guarantee free-of-charge early access for triple negative secondary breast cancer patients.
The charity cites a recent interim access agreement made for the first Project Orbis drug, a lung cancer drug, to be available on the NHS for patients as a precedent for Gilead to follow suit.5
Baroness Delyth Morgan, Chief Executive at Breast Cancer Now, said:
“There are hundreds of women living with triple negative secondary breast cancer who are holding out hope of potentially benefitting from the promise of extra months Trodelvy could offer and it is incredible to see people uniting behind our calls to ensure they get life-changing access to this exciting new treatment.
“Thank you to everyone who has already signed the petition to call on Gilead to provide Trodelvy free of charge, until it is assessed for routine use on the NHS. The more people that sign the petition, the more likely it is that we will be able to ensure this treatment quickly reaches those women who desperately need it and who simply do not have time to wait. If you haven’t yet signed, please join us and help us start to turn the tide on triple negative secondary breast cancer.”
Gilead and NHS decision-makers in the devolved nations will also need to guarantee that patients in Wales, Scotland and Northern Ireland have equal access to Trodelvy following licensing so that eligible patients across the UK have the chance to potentially benefit from this drug. Breast Cancer Now also want to see the MHRA, NICE and NHS England working together with stakeholders to deliver an integrated, timely approach for NHS patients to access treatments licensed through Project Orbis, the new route introduced in January.
Sign Breast Cancer Now’s ‘It’s Time for Trodelvy’ petition now: breastcancernow.org/trodelvy
Notes to Editors:
1. Sacituzumab govitecan (Trodelvy) is a targeted (biological) therapy. It delivers a chemotherapy drug straight to cancer cells which have the protein Trop-2 on their surface. This is the case in many types of cancer, including breast cancer. This treatment is suitable for patients with unresectable locally advanced or secondary triple negative breast cancer who have had at least two prior therapies.
2. The exact date when Trodelvy will be licensed is not in the public domain, but we are expecting it to be published shortly. The NICE appraisal for the treatment is currently in development and the provisional schedule suggests that publication will be in June 2022.
3. There is no exact number on how many patients may be eligible for this drug and there remains a wider issue around lack of data about how many people are living with secondary breast cancer and the treatments they are receiving meaning it’s not possible to calculate how many people may be receiving certain treatments. Around 15% of all breast cancers – over 8,000 cases a year in the UK – are triple negative, but we do not have numbers for how many women with locally advanced or secondary breast cancer have triple negative breast cancer. We would estimate that hundreds of people may be able to access this drug if an interim access agreement was put in place.
4. 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. Among all randomly assigned patients (those with or without brain metastases), the median progression free survival was 4.8 months with sacituzumab govitecan and 1.7 months with chemotherapy. For the same population, the median overall survival was 11.8 months with sacituzumab govitecan and 6.9 months with chemotherapy. In patients without brain metastases the median progression free survival was 5.6 months with sacituzumab govitecan and 1.7 months with chemotherapy. And the median overall survival was 12.1 months with sacituzumab govitecan and 6.7 months with chemotherapy.
Project Orbis is a programme coordinated by the US Food and Drug Administration (FDA) involving the regulatory authorities of Canada, Australia, Switzerland, Singapore, Brazil, and the UK. It provides a framework for concurrent submission and review of oncology products for licensing among international partners. It aims to deliver faster patient access to innovative cancer treatments with potential benefits over existing therapies. Each country remains fully independent on their final regulatory decision. The MHRA joined this scheme in January 2021 following the end of the transition period. Applications submitted to the MHRA within a Project Orbis procedure are applicable to Great Britain only.
Secondary breast cancer
It is not currently known how many people have secondary breast cancer (cancer that has spread to another part of the body), however estimates suggest that 35,000 people in the UK are living with this devastating incurable disease. [Yip, K., McConnell, H., Alonzi, R., & Maher, J. (2015). Using routinely collected data to stratify prostate cancer patients into phases of care in the United Kingdom: implications for resource allocation and the cancer survivorship programme. British Journal of Cancer, 112, 1594–1602]
Triple negative breast cancer
This is the name given to breast cancers that lack the three receptors which are normally used to classify breast cancers: oestrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER2). Around 15% of all breast cancers – over 8,000 cases a year in the UK – are triple negative.
Triple negative breast cancer is more common in:
- Women who have inherited an altered BRCA gene
- Black women
- Women who have not yet reached the menopause
- Women under 40