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Medicines licensing

FDA approves rucaparib for ovarian cancer

The US Food and Drug Administration (FDA) has approved rucaparib (Rubraca; Clovis Oncology) for ovarian cancer in women with BRCA mutations.

The drug, a poly-adenosine diphosphate-ribose polymerase (PARP) inhibitor, is indicated for women with advanced disease who have been treated with two or more chemotherapies. A BRCA mutation must be identified via a designated FDA-approved diagnostic test.

The drug was approved via the FDA’s accelerated programme and the decision was based on a surrogate endpoint of overall response rate. Data were taken from two single-arm trials involving 106 patients, 96% of whom had a confirmed BRCA mutation.

The trials reported an overall response rate of 54% — the percentage of patients who had a complete or partial shrinkage of their tumours. The most common side effects included nausea, vomiting, anaemia, abdominal pain and diarrhoea. The most serious adverse events were myelodysplastic syndrome, acute myeloid leukaemia and fetal harm. Confirmatory studies are ongoing with progression-free survival as an end point.

The FDA recommends that patients are monitored for haematologic toxicity throughout treatment.

Sir Harpal Kumar, chief executive of Cancer Research UK, says the charity is delighted by the approval, noting that UK-based researchers funded by the charity were involved in discovering and developing the drug in the early 1980s.

“The drug — one of an exciting group of drugs that exploit the weaknesses cancer cells have in repairing damaged DNA — will offer new hope to women with advanced ovarian cancer. We hope it could one day treat other cancer types and clinical trials are under way to discover its potential.”

Clovis Oncology submitted a marketing authorisation application to the European Medicines Agency in November 2016.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2016.20202127

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