Ipsen wins MHRA’s approval for its breast cancer drug

Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK, in coordination with fourteen other European regulatory agencies, has approved a new indication for Ipsen’s Decapeptyl as adjuvant treatment in combination with tamoxifen or an aromatase inhibitor, of endocrine-responsive early-stage breast cancer in women at high-risk of recurrence who are confirmed as pre-menopausal after completion of chemotherapy.

Alexandre Lebeaut, Executive Vice President, R&D, Chief Scientific Officer, Ipsen stated: “This is the result of a longstanding scientific collaboration between Ipsen and the IBCSG, one of the leading international cooperative groups in Breast Cancer.”

As the company explained, the approval is based on international trials sponsored by the International Breast Cancer Study Group (IBCSG). Two randomized Phase 3 trials were conducted, SOFT (Suppression of Ovarian Function Trial) and TEXT (Tamoxifen and Exemestane Trial), which evaluated pre-menopausal women with early-stage hormone-receptor-positive breast cancer.

On the basis of results from SOFT and TEXT studies, the international guidelines of St Gallen, the European Society for Medical Oncology (ESMO), the National Comprehensive Cancer Network (NCCN) and ASCO have 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 recurrence, the company said.