Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK, in coordination with fourteen other European regulatory agencies, has approved a new indication for 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: “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. This is the result of a longstanding scientific collaboration between Ipsen and the IBCSG, one of the leading international cooperative groups in Breast Cancer which exemplifies Ipsen’s continuous commitment to improving patients care.”
The approval is based on international trials sponsored by the International Breast Cancer Study Group (IBCSG) and conducted on a total of 5,700 randomized patients in 27 countries. 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.
The IBCSG presented the combined results of the TEXT and SOFT clinical trials at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting plenary session in Chicago and the 2014 San Antonio Breast Cancer Symposium. Results were published in the New England Journal of Medicine1;2.
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.
Meredith M. Regan, Associate Professor in the Department of Biostatistics and Computational Biology at the Dana-Farber Cancer Institute, Associate Professor of Medicine at Harvard Medical School, IBCSG Group Statistician, commented: “IBCSG initiated those 2 prospective studies SOFT and TEXT more than fifteen years ago with the ambitious goal to address a major question on the role of OFS in the adjuvant setting for premenopausal women. We are very happy that these studies have been the foundation for a MHRA approval of triptorelin which will facilitate patient’s access to this new treatment paradigm. We thank Ipsen for their support since the beginning of those studies”.
1 Pagani O, Regan MM, Walley BA, et al.: Adjuvant exemestane with ovarian suppression in premenopausal breast cancer N Engl J Med 2014; 371: 107–118.
2 Francis PA, Regan MM, Fleming GF, et al.: Adjuvant ovarian suppression in premenopausal breast cancer. N Engl J Med 2015; 372: 436–446.