18 July 2021

Today (Sunday 18 July), charity Breast Cancer Now has launched a petition calling on pharmaceutical company, Gilead, to provide free-of-charge access to exciting new treatment Trodelvy1 (sacituzumab govitecan) for eligible patients with triple negative incurable secondary breast cancer - once the drug is licensed and ahead of a decision being made around its routine use on the NHS next year.

In England alone, hundreds of women who are living with this life-limiting disease could face the prospect of being denied the chance of Trodelvy potentially bringing them precious extra time with their loved ones due to the delay between licensing of the drug – expected in the coming months - and a decision being made (2022) on it being made routinely available on the NHS.2

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 35,000 people in the UK are living with this devastating incurable disease, and the fear and uncertainty around when it will cut their lives short.3 Those with triple negative secondary breast cancer can face shorter prognoses and fewer treatment options, but Trodelvy could offer them hope of extra months with loved ones and to do things that matter most to them.4

Breast Cancer Now has raised with both Gilead and NHS England the vital need to grant interim access to Trodelvy, as soon as the drug is licensed, to guarantee that it quickly reaches these women who so desperately need it and don’t have time to wait. Now urgent action is needed.

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 and is calling on Gilead to follow suit by working with NHS England and providing Trodelvy free-of-charge on the NHS on a short-term basis.5

Breast Cancer Now’s newly launched ‘It’s Time for Trodelvy’ petition seeks to secure this life-changing early access for patients.

Beth Coppin, 37, from Kent was diagnosed with breast cancer in 2015 while pregnant with her second son, and a year and a half later was given the news that she had triple negative incurable secondary breast cancer. She says:

“I have had various chemotherapy drugs to control my cancer. Each treatment has worked for a short time but then my cancer adapts. Once the drug I am on now stops working there is nothing new to try. I desperately need access to Trodelvy now to extend my life, otherwise I may well die before the end of the summer holidays. My boys are five and six years old. Trodelvy could give me up to six extra months with them and I would be grateful for every moment.” 

Baroness Delyth Morgan, Chief Executive at Breast Cancer Now, said:

“Trodelvy offers some women living with triple negative secondary breast cancer the life-changing chance of extra months with friends and family and to be here for more moments that matter. It’s a tragic state of affairs that women already facing limited treatment options could be denied the hope of potentially benefitting from this promising drug if Gilead does not provide Trodelvy free-of-charge.

“These women, who are already facing heartbreakingly short prognoses, simply do not have time to wait for the treatments they so desperately need. That’s why we are launching a petition today that urgently calls on Gilead to provide Trodelvy free of charge, until it is assessed for routine use on the NHS. They must do the right thing and come to an agreement with NHS England to allow this to happen.

“We know the impact of uniting to call for the right thing for breast cancer patients and this is why we are calling on people to sign our petition now, to 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

ENDS

For further information or to arrange an interview with a case study or a spokesperson, please contact Breast Cancer Now’s press office at press@breastcancernow.org or on 07436 107 914.

Case studies:

Philippa Hetherington, 37, from London, is a historian, and was diagnosed with breast cancer in March 2019 when she was 35, after noticing redness on the skin of her breast. In May 2020 Philippa started having chest pains and a scan in A&E detected something on her lung. It wasn’t thought to be suspicious, but a second scan in November confirmed that the breast cancer had spread to Philippa’s lungs and was incurable triple negative breast cancer. She says:

“Being diagnosed with incurable secondary breast cancer was devastating, and being all alone due to COVID-19 restrictions was a miserable experience. The first words my oncologist said to me was “I’m sorry to tell you over the phone”.

“Despite treatment, my cancer has continued to spread, including to my brain. I don’t yet know if my current treatment is working, and if it is I don’t know how long it will work for. So I could need Trodelvy very soon to give me important hope of extra time, which would mean the world to me. I want to travel back to Australia post-covid to see all my family again, and to complete the book I’ve been writing for 10 years – I don’t want to die before finishing it.

“Right now I’m incredibly frightened and worried about my lack of treatment options if Trodelvy isn’t available when I need it - it feels like doors are being closed and the possibility of more time taken away from me. It is totally unfair and unjust that women could die while waiting for this treatment when there is such a clear solution.” 

Miranda Johnson, 51, from Lincolnshire, was first diagnosed with hormone positive breast cancer in 2008 when she was 38 years old, and in 2020 was given the devastating news that she had triple negative incurable secondary breast cancer in her lymph nodes and extensively in her spine, with limited treatment options. She says:

“Although I consider myself lucky to be having chemotherapy currently, I worry about the point when it stops working, which it will.

“Access to Trodelvy, when the time comes, could give me many more precious months to spend with my husband, my three children and two - soon to be three – grandchildren, which is so important to me. It’s so crucial that people living with secondary breast cancer get a fairer deal, and access to these vital treatments when we need them, especially those of us living with triple negative with such a poor life expectancy.

“These past 18 months spent shielding have been incredibly hard and lonely, with very little freedom. Now, while others are finally able to enjoy restrictions lifting, for me, it’s just a kick in the teeth. I just desperately hope that access to Trodelvy is granted and I, and other women in this situation, can have more time when we are further through this pandemic.”

Beth Coppin, 37, from Kent was diagnosed with breast cancer in 2015 aged 32 while pregnant with her second son. Beth’s cancer spread to her bones and distant lymph nodes a year and a half later and she was given the news that she had secondary breast cancer. Beth’s breast cancer is now triple negative and has spread more widely. She is currently receiving chemotherapy and has a short life expectancy. She says:

“I have had various chemotherapy drugs to control my cancer. Each treatment has worked for a short time but then my cancer adapts. Once the drug I am on now stops working there is nothing new to try. I desperately need access to Trodelvy now to extend my life, otherwise I may well die before the end of the summer holidays. My boys are five and six years old. Trodelvy could give me up to six extra months with them and I would be grateful for every moment.” 

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. 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.

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. 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

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.

5. May 2021 https://www.gov.uk/government/news/uk-medicines-regulator-issues-its-first-authorisation-under-project-orbis

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.

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