Trodelvy, a drug that gives hope to those with the most severe form of metastatic breast cancer, Triple Negative Breast Cancer (TNBC) is being denied to British women.
Triple Negative Breast Cancer (TNBC) is the hardest cancer to treat with the worst prognosis disproportionately affecting young women and women of colour.
The average life expectancy for someone with metastatic TNBC is just 12-18 months.
Breast cancer drug's accelerated approval in the US
Trodelvy was given given accelerated approval by the Federal Drugs Administration (FDA) in the United States on April 22 2020. It received this on the basis of remarkable clinical trial results that showed that Trodelvy can work to shrink cancer in patients who are otherwise resistant to chemotherapy.
For certain subgroups of patients (such as those who express the protein Trop-2, very common in TNBC) 44% of patients saw shrinkage of 20% or more of their tumors, versus just 1% of patients who did on standard of care chemotherapy. In April this year Trodelvy received full FDA approval after a Phase 3 trial confirmed that Trodelvy reduced the risk of death for TNBC patients by 49% compared to standard chemotherapy. Trodelvy has offered a crucial lifeline to a poor-prognosis patient population desperate for options. It has given hope to Triple Negative Breast Cancer patients who until now have missed out on the advances seen in other subtypes of breast cancer.
Unfortunately, it still has not been approved for British women.
For a drug to be approved and then funded on the NHS in the UK there is a two step process: first, licensing by the Medicines and Healthcare Regulatory Authority (MHRA), and second, NHS funding approval by the National Institute for Health and Care Excellent (NICE). Gilead, the drug company that owns and markets Trodelvy, applied for MHRA licensing in January 2021.
When the application was made in January 2021,the oncology community hoped that licensing would be complete by June 2021 (thus matching the 150-day deadline the MHRA sets out for its regular accelerated approval process). However, recent signals have indicated that a decision on approval will not meet this deadline, and may even take until the end of 2021.
Post-Brexit failure of Project Orbis
‘We have been promised faster drug approval, in the form of a new, post-Brexit system called Project Orbis which has been hyped by the government as a way that British patients will get faster access to vital cancer drugs,’ says Jo Taylor of Met Up UK, the patient advocacy group for patients with secondary/metastatic breast cancer.
In this system, which is administered by the FDA and involves a consortium of countries including the UK, Australia and Switzerland, drugs which have already been approved by the FDA undergo a faster approval process in other consortium countries. Trodelvy would seem the perfect test case for this new system, and as such constitutes a test case for the new, post-Brexit cancer drug approvals environment.
‘The signs that Project Orbis will be a boon for cancer patients are not good, if the Trodelvy experience is anything to go by, comments Jo Taylor. ‘It was hoped that licensing would be complete by June 2021. In other words, the new, fancy post-Brexit approval system may still see it take up to a year for a licensing decision on Trodelvy. A year in which 1650 women will die of metastatic TNBC, women whose lives could have been extended and vastly improved by access to this life-saving drug.’
Stage 4 cancer patients abandoned
Jo adds: ‘The experience of the Covid vaccine has shown us that, when the will is there, new drugs can go from lab to patient quickly. Why are Stage 4 cancer patients being left behind, forgotten and marginalised yet again? We call on the government to intervene to speed up the MHRA process for the approval of Trodelvy to show it is actually committed to improving access to lifesaving drugs in the post-Brexit regulatory environment. People are dying. The wheels of change are too slow for this aggressive subtype of breast cancer.’