Pierre Fabre Médicament obtains MA in China for NAVELBINE®Oral (Vinorelbine*)in the treatment of advanced lung and breast cancer
September 22, 2014
Castres, September 22, 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.” 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**, these pathologies are a major public health burden.
In 1989 NAVELBINE® received marketing authorization (MA) for Europe for the indication of Non- Small Cell Lung Cancer (NSCLC). In 1991, this MA was followed by marketing authorizationfor the indication of metastatic breast cancer. NAVELBINE® has since been registered for NSCLC and/or breast cancer indications in over 90 countries, including the USA in 1994. In 2001 the oral form obtained MA, and this formulation is currently registered in 53 countries.
Oral chemotherapy improves out-patient care, one of the major objectives of the 2014 Cancer Plan established by the French Health Authorities. NAVELBINE® Oral offers efficacy and tolerance similar to those of the intravenous formulation with the advantages of oral administration, associated with improved comfort for the patient.
* In the form of ditartrate
**: Source WHO http://www.iarc.fr/fr/mediacentre/pr/2013/pdfs/pr223_F.pdf
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