4. Tyrosine kinase Oncology The sponsor’s inhibitors are seen as response is Several angiogenesis promising treatment acceptable. inhibitors, such as options for different types bevacizumab, sunitinib and of solid tumours. Trial sorafenib are currently 1199.15 U09-1763 is an approved for the treatment of example of investigating a broad spectrum of different nintedanib for the oncological indications. treatment of ovarian Therefore, off label use of cancer. In addition, clinical nintedanib in patients with trials are also underway to cancers for which alternative investigate the angiogenesis inhibitors are combination treatment of approved and available is nintedanib with drugs considered unlikely. other than docetaxel. Efficacy and safety of Therefore, the off label use nintedanib in combination of nintedanib is highly with docetaxel have been likely. The sponsor should established for the treatment add label use’ as ‘off of adult patients with locally information’ in ‘missing advanced, metastatic or the ASA for both Vargatef locally recurrent NSCLC of and Ofev. adenocarcinoma tumour histology after first line chemotherapy. Nintedanib is in development in further oncology indications. The sponsor does not encourage the use of nintedanib outside the terms of an approved indication. However such use may occur particularly in cancer patients for whom treatment options are exhausted. Use in these patients is frequently based on published clinical data (or standard treatment guidelines). Information of off label use with and without ADR will be collected, and periodically assessed using routine pharmacovigilance activities. The sponsor does not intend to add label use’ as ‘off missing information in the ASA for NSCLC. IPF IPF is a specific form of chronic, progressive fibrosing interstitial pneumonia of
4. Tyrosine kinase inhibitors are seen as promising treatment options for different types of solid tumours. Trial 1199.15 U09-1763 is an example of investigating nintedanib for the treatment of ovarian cancer. In addition, clinical trials are also underway to investigate the combination treatment of nintedanib with drugs other than docetaxel. Therefore, the off label use of nintedanib is highly likely. The sponsor should add ‘off label use’ as ‘missing information’ in the ASA for both Vargatef and Ofev. Oncology Several angiogenesis inhibitors, such as bevacizumab, sunitinib and sorafenib are currently approved for the treatment of a broad spectrum of different oncological indications. Therefore, off label use of nintedanib in patients with cancers for which alternative angiogenesis inhibitors are approved and available is considered unlikely. Efficacy and safety of nintedanib in combination with docetaxel have been established for the treatment of adult patients with locally advanced, metastatic or locally recurrent NSCLC of adenocarcinoma tumour histology after first line chemotherapy. Nintedanib is in development in further oncology indications. The sponsor does not encourage the use of nintedanib outside the terms of an approved indication. However such use may occur particularly in cancer patients for whom treatment options are exhausted. Use in these patients is frequently based on published clinical data (or standard treatment guidelines). Information of off label use with and without ADR will be collected, and periodically assessed using routine pharmacovigilance activities. The sponsor does not intend to add ‘off label use’ as missing information in the ASA for NSCLC. IPF IPF is a specific form of chronic, progressive fibrosing interstitial pneumonia of The sponsor’s response is acceptable.