Pierre Fabre Médicament obtains MA in China for NAVELBINE®Oral (Vinorelbine*)

September 24, 2014

Pierre Fabre Médicament announced that it had obtained marketing authorization (MA) in China from the CFDA (China Food and Drug Administration) for NAVELBINE®Oral in monotherapy or in association, for the treatment of locally advanced, unresectable, non-small cell lung cancer and for advanced breast cancer.

This authorization follows the filing of the registration dossier in 2010, which included the results of two randomized studies conducted by Pierre Fabre in China since 2008, the date of inclusion of the first patient. These studies, which were performed on Chinese patients, have helped to validate the interest of NAVELBINE®Oral in the first-line treatment of patients with lung cancer or metastatic breast cancer.

The availability of oral chemotherapy in China will help facilitate out-patient care for many patients suffering from lung or breast cancer. This authorization marks an important stage in the international development of the pharmaceutical division and more particularly of its oncology franchise declared Frédéric Duchesne, President of Pierre Fabre Médicament.

The number of patients treated for cancer is growing in China, particularly due to improved screening and better patient management. Lung and breast cancers are among the main cancers affecting the Chinese population. With over 19.3 million new cancer cases each year worldwide between now and 2025 (source OMS,these pathologies are a major public health burden.

* In the form of ditartrate