The US Food and Drug Administration (FDA) has today approved the drug olaparib (Lynparza) for the treatment of patients with BCRA-mutant metastatic breast cancer in the United States.

Monday 15 January 2018      Campaigns and policy

In June 2017, a major phase-III trial presented at the American Society for Clinical Oncology (ASCO) Conference demonstrated that olaparib can give women living with BRCA-mutated incurable breast cancer significant extra time before their disease progresses, compared to standard chemotherapy.

The OlympiAD trial, led by scientists at the Memorial Sloan Kettering Cancer Center in New York and funded by AstraZeneca, tested olaparib versus chemotherapy for patients with HER2-negative BRCA-mutated advanced breast cancer. It found that olaparib delayed progression by an average of around 3 months, compared to chemotherapy (7.0 months vs 4.2 months respectively).

Olaparib – which is one of a new class of drugs known as PARP inhibitors – was first developed as a cancer treatment following landmark research by UK scientists at the Breast Cancer Now Research Centre at The Institute of Cancer Research, London in 2005, who demonstrated for the first time that cancer cells with BRCA1 and BRCA2 mutations were very sensitive to PARP inhibitors.

The drug works by blocking a DNA repair protein known as PARP, which can help BRCA-mutated cancer cells survive despite their main DNA repair kits (BRCA1 or BRCA2) not functioning properly. By blocking PARP with olaparib, breast cancer cells which have BRCA mutations can be rendered unable to repair their DNA – causing them to die.

Fiona Hazell, Director of Policy and Engagement at Breast Cancer Now, said:

“This drug represents a significant step forward in the treatment of BRCA-mutant secondary breast cancer, and its approval by the FDA is very promising news. Olaparib could soon become one of the first biologically targeted drugs for a group of patients with incurable and aggressive breast cancer who currently have few treatment options.

“This important drug can offer around three extra months before the disease progresses compared to chemotherapy – and a better quality of life during that time – which could be invaluable to so many women and their families. The drug also represents a fantastic achievement for UK science, with PARP inhibitors first being developed as a cancer treatment following research at the Breast Cancer Now Research Centre at The Institute of Cancer Research, London in 2005.

“Having been fast-tracked for approval in the United States, we now look forward to olaparib being submitted to the EMA (European Medicines Agency) for licensing in this indication to open the door for future access for UK patients, as well as research to uncover how we can best identify which patients will benefit the most.”