1280 British breast cancer sufferers have voiced concerns that a potentially ground-breaking cancer treatment drug (Olaparib) is still waiting to be approved for NHS use almost two years after it was given the green light in the United States.
The Approval of Olaparib
The drug, Olaparib, was granted a licence by the European Medicines Agency (EMA) in 2014 for use in women and men with advanced breast cancer who have inherited BRCA gene mutations – a condition present in roughly 0.25% of the population that affects the body’s ability to repair DNA and prevent breast cancer.
Olaparib works by inhibiting an enzyme known as poly ADP ribose polymerase (PARP), which cancerous cells need to spread. The drug was developed by British scientists at the Institute of Cancer Research (ICR), who demonstrated in 2005 that cancer cells with BRCA1 and BRCA2 mutations were extremely sensitive to this.
However, the National Institute for Health and Care Excellence (NICE) has put the appraisal process on hold until mid-July 2019.
In December 2018, a separate report by the ICR found that red tape in British research and approval processes led to NHS patients waiting longer for new cancer drugs. The study found that between 2000 and 2008 it took an average of 12.7 years to take a drug from patent to approval by NICE. From 2009 to 2016 the average was 14.1 years.
Other experts have claimed that differences in the type of evidence accepted by regulators could explain the delay. However, the ICR has said that regulators need to become more comfortable with results from smaller trials involving patients selected by the genetics of their cancer.
In the case of Olaparib, the NICE process was paused after the manufacturer AstraZeneca asked to include “key additional data”.
A spokeswoman for NICE said: “We are working to ensure access for patients with BRCA-mutated metastatic breast cancer as quickly as possible.”
However, Paul Workman, chief executive of the ICR, said: “It’s taking far too long for pioneering drugs to reach patients and we need to do more to fast-track the most exciting new treatments into the NHS.”
Baroness Morgan of Drefelin, the chief executive of Breast Cancer Care and Breast Cancer Now, also voiced worries over the hold-up, commenting: “The delay in Olaparib’s appraisal for use on the NHS is extremely concerning and we urge NICE and AstraZeneca to make clear why this has happened.”