10 September 2021

Today’s news of the licensing of Trodelvy1 (sacituzumab govitecan) brings little comfort to women with triple negative incurable secondary breast cancer as pharmaceutical company Gilead failed to reach an agreement with NHS England to provide the drug free-of-charge to eligible patients, ahead of a NICE decision on routine NHS access next year.

Instead, hundreds of women2 in England who already face short prognoses and limited treatment options could now face an agonising wait of up to eight months to access Trodelvy3 and the chance it brings of precious extra time with loved ones and doing what matters most to them.

Trodelvy’s licensing through the Project Orbis scheme, which the MHRA joined at the start of the year, comes only a day after that of a lung cancer drug, Sotorasib, and four months after another drug, both of which were successfully made immediately available to patients following licensing via an interim access scheme agreed by the drug companies Amgen and AstraZeneca with NHS England.4

Gilead will introduce a pre-reimbursement access scheme for Trodelvy shortly after licensing, but this limited scheme will not guarantee that all women who need this drug will be able to receive it.5

Breast Cancer Now is calling on the public to sign their ‘It’s Time for Trodelvy’ petition which calls on Gilead to provide the drug free-of-charge on the NHS to all eligible women who desperately need it and don’t have time to wait.

Emma Metcalfe, 35, from Sheffield, was diagnosed with triple negative secondary breast cancer in January, a year after first being diagnosed with primary breast cancer during the COVID-19 pandemic. She said:

“Being told I had incurable breast cancer was a really dark time - having to tell my parents and brothers over the phone and lying awake cuddling my partner and crying together in the dark. I’m already on my second line of treatment since my secondary breast cancer diagnosis, my cancer is aggressive and doesn’t take long to outsmart whatever chemo drug we throw at it.

“I worry about my treatment stopping working and I’m painfully aware that I’m fast running out of options. That’s why Trodelvy is so important. I love my life and I still have so much more I want to do and this treatment could offer me more time. Knowing that Trodelvy is there but I can’t access it is incredibly frightening. It’s heart-breaking to think I could miss out on this new drug by as little as a few months.”

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

“The tragic reality is that despite today’s licensing of Trodelvy, women with incurable triple negative secondary breast cancer may now face an agonising wait of up to eight months to access this exciting new treatment that they so desperately need – and for many this will be too late.

“These women are paying the ultimate price for drug company Gilead’s failure to reach an agreement with NHS England which could have seen eligible patients accessing Trodelvy free-of-charge on the NHS from today, ahead of a decision around its routine use in 2022. This is a bitter pill to swallow. Just as both Amgen and AstraZeneca recently used the process in place to make this happen for lung cancer patients, Gilead must do the same for breast cancer.

“Gilead’s proposed pre-reimbursement access scheme falls alarmingly short of what’s needed and will not guarantee all eligible women access to Trodelvy. These women don’t have time to wait. Gilead must urgently do the right thing for breast cancer patients by reaching an agreement with NHS England so that all eligible women are granted access to Trodelvy without delay; until then with every extra day that goes by there will be women who heartbreakingly are denied the chance of more time to live.6

“Sign our ‘It’s Time for Trodelvy’ petition now to help us turn the tide on triple negative secondary breast cancer.”

Dr Andreas Makris, Consultant Clinical Oncologist at the Mount Vernon cancer Centre and co-Chair of the UK Breast Cancer Group, said:

“Trodelvy is a major advance for the treatment of secondary (metastatic) triple negative breast cancer, an aggressive form of the disease. Until now these patients have been faced with limited treatment options. Trodelvy has been shown to help women with the disease to live longer and it’s vital that women in the UK are able to access it immediately to give them the best chance of having more time with their loved ones.”

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 get the chance to potentially benefit from this drug. Breast Cancer Now is calling on the MHRA, NICE and NHS England to come together and, with stakeholders, urgently develop a sustainable, integrated and timely approach to ensure all NHS patients can access treatments licensed through Project Orbis, the new scheme 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:

Lorna Whiston, 27, from Crewe was diagnosed with triple negative secondary breast cancer in November 2020, after first being diagnosed with primary breast cancer in February 2019 and needs access to Trodelvy to give her the chance of more time with her young family. She said:

“I was 4 days post giving birth to my twins by planned section when I was given the news. The shadow on my chest was breast cancer again. However, this time, it is stage 4. All I could think of was my babies and my 4-year-old. I’m now on my second line of treatment after the first stopped working and I’m consciously aware of the limited options a triple negative secondary breast cancer diagnosis has for treatment.

“Juggling treatment, twins and a pre-schooler is difficult, but we muddle through. I married the love of my life earlier this year and we’ve bought a family home. I have too much to do and too many memories to make. Trodelvy gives someone like me hope, hope that I will see my twins’ first steps, that I’ll see my son at his first sports day. I’m 27. It’s not my time. I’m not ready.”

Sophie Abbott, 57, from London, has been living with triple negative secondary breast cancer for four years. 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.”

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.

3. The NICE appraisal for Trodelvy is currently in development and the provisional schedule suggests that the committee meeting will take place on 15 March 2022 so a decision will follow shortly after this. 

4. September 2021 https://www.england.nhs.uk/2021/09/lung-cancer-patients-to-get-breakthrough-drug-on-nhs/; 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.

5. Gilead will introduce a limited pre-reimbursement access scheme for Trodelvy shortly after licensing that will be free-of-charge.

6. 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. The median overall survival was 12.1 months with sacituzumab govitecan and 6.7 months with chemotherapy.

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

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