Ipsen’s Decapeptyl approved by MHRA in new indication

Ipsen has announced that its cancer drug Decapeptyl (tamoxifen) has been approved by the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) in a new indication.

In coordination with 14 other European regulatory agencies, the regulator has approved Decapeptyl as an adjuvant treatment for endocrine-responsive early-stage breast cancer, in combination with tamoxifen or an aromatase inhibitor.

The therapy is designed for use in women at high risk of recurrence for breast cancer who have been confirmed as pre-menopausal after the completion of chemotherapy. This approval was based on data from clinical studies involving 5,700 randomised patients in 27 countries.

Based on results from the phase III SOFT and TEXT studies, the international guidelines of St Gallen, the European Society for Medical Oncology, the National Comprehensive Cancer Network and ASCO have all been updated to recommend the use of ovarian function suppression with either tamoxifen or exemestane as a new therapeutic option for women at high risk of breast cancer recurrence.

Alexandre Lebeaut, executive vice-president for research and development and chief scientific officer at Ipsen, said: "We are pleased to receive the first European approval, which brings a new treatment option offering disease-free survival benefit for high-risk pre-menopausal breast cancer patients."

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