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September 8, 2022

MHRA grants marketing authorisation for olaparib to treat breast cancer

In the Phase III OlympiA trial, olaparib plus standard therapy provided a 32% reduction in mortality risk.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Merck and AstraZeneca’s precision drug, olaparib, to treat high-risk, early-stage breast cancer patients.

The treatment is indicated for such patients with inherited defects in BRCA1 or BRCA2 genes.

It provides women with early-stage, inherited breast cancer an alternate therapy option to aid in preventing the recurrence of cancer and boost their survival.

At present, an appraisal by the National Institute for Health and Care Excellence (NICE) is progressing to check if olaparib could be supplied through the NHS for such patients.

A decision from the institute is anticipated early next year.

The latest development comes after the drug obtained similar approvals from the European Medicines Agency (EMA) and the US Food and Drug Administration.

According to findings from the Phase III OlympiA clinical trial, olaparib plus standard therapy provided a 32% reduction in mortality risk after a follow-up of an average of three and a half years in patients with increased-risk, early-stage breast cancer and inherited defects in BRCA genes.

Previously, the trial had met its primary endpoint indicating that olaparib lowered breast cancer recurrence risk in such patients by 42%. 

Olaparib is an inhibitor of poly ADP ribose polymerase (PARP).

OlympiA trial global chair professor Andrew Tutt said: “For patients with high-risk, early-stage breast cancer, including those with inherited BRCA mutations, recurrence rates remain unacceptably high, with more than one in four of these patients seeing their cancer return following surgery and other current treatments.

“Olaparib offers the first treatment that exploits the specific biology of this inherited type of breast cancer to reduce the risk of cancer returning and improve survival in women diagnosed with early-stage disease.”

In August, the European Commission (EC) approved olaparib as a single agent or in combination with endocrine therapy for adjuvant treatment in adults with high-risk, early-stage breast cancer.

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