European Medicines Agency approves olaparib for women with BRCA-mutant breast cancer – 15 months after licensing in the US. The targeted cancer drug olaparib has been approved by the European Medicines Agency (EMA) for women and men with advanced breast cancer who have inherited BRCA gene mutations.
The decision comes 15 months after the drug was approved for breast cancer in the US by the Food and Drug Administration. NICE has paused its appraisal of olaparib for NHS patients with breast cancer while waiting for manufacturer AstraZeneca to submit new data, and is not now planning to restart its review until around July.
The Institute of Cancer Research, London, discovered the genetic targeting of olaparib – which became the first cancer drug directed against an inherited genetic fault when licensed by the EMA for BRCA-mutation ovarian cancer in December 2014 . In a statement, the ICR welcomed the approval of olaparib for breast cancer as an important step towards making it available for NHS patients – but also criticised delays in making the drug available in Europe.
Professor Paul Workman, Chief Executive of the ICR, said:
“It’s fantastic news that olaparib has finally been given the green light by the EMA for people with BRCA-mutant breast cancer. But it’s also been enormously frustrating for patients across Europe to have had to wait so long to get the drug.
“Olaparib is an extremely innovative treatment which was the first cancer drug in the world to target inherited genetic faults. Yet it’s taking far too long for pioneering drugs like this to reach patients and we need to do more to fast-track the most exciting new treatments into the NHS.
“The EMA and NICE have started to be more nimble and flexible in their evaluation of evidence, but there is still more they could do and much that they could learn from best practice in the US and elsewhere.”
Researchers at The Breast Cancer Now Toby Robins Research Centre lead important study programmes to understand the genetic and environmental causes of breast cancer.
Professor Andrew Tutt, who is Director of the Breast Cancer Now Research Centre at the ICR, was part of the early laboratory research at the ICR behind PARP inhibitors in patients with BRCA mutations, and led some of the early clinical trials of olaparib for BRCA-mutant breast cancer.Responding to the decision, Professor Tutt said:“Although the delays have been disappointing, I am delighted olaparib has now been licensed in Europe for advanced breast cancer in women who have inherited BRCA1 or BRCA2 mutations. It is excellent news for patients with this form of breast cancer. “Olaparib is the first drug to be approved that is directed against an inherited genetic mutation. It is a perfect example of how understanding a patient’s genetics and the biology of their tumour can be used to target its weaknesses and personalise treatment.”
Emma Clarke, 46 from Cheshire, was diagnosed with primary breast cancer in 2016, and secondary breast cancer spread to her bones in 2018. Later genetic testing discovered she carried a BRCA1 mutation. She is currently being treated with chemotherapy and is due to begin radiotherapy soon. Her daughter recently discovered she also has the BRCA1 mutation. Emma said: “I have done a lot of research into my type of cancer – about having a BRCA1 mutation and the possible treatments available for me. Because I have the BRCA1 mutation, and that carboplatin is working well for me at the moment, I found out that olaparib has a good chance or working well for me and that it is already available in the US. “I’m fortunate enough to be a private patient and have asked my doctor about starting olaparib, which I will begin taking as a maintenance treatment when my radiotherapy finishes in June. “I whole heartedly support progress in targeted therapies and getting these to patients as soon as possible. Targeted therapies are at the forefront of treatments for patients, and give such hope at extending lives while living with fewer side effects than traditional chemotherapies. “I was really surprised to see the length of the time gap between olaparib being available in the US and it being approved by the EMA. I hope for all the other BRCA+ breast cancer patients in this country that it is available on the NHS as soon as possible. “With advanced-staged cancers like my own, once you have good evidence that a new targeted treatment is shown to work and extend lives, it should be available to patients.”