On 25 September 2014, the European Medicines Agency‘s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product nintedanib (Vargatef), 100 and 150 mg, soft capsules intended in combination with docetaxel for the treatment of locally-advanced, metastatic or locally-recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first-line chemotherapy.
The applicant for this medicinal product is Boehringer Ingelheim International GmbH. They may request a re-examination of any CHMP opinion, provided they notify the European Medicines Agency in writing of their intention within 15 days of receipt of the opinion.
The active substance of Vargatef is nintedanib, a tyrosine kinase inhibitor anti-neoplastic agent blocking vascular endothelial growth factor receptors (VEGFR1-3), platelet-derived growth factor receptors (PDGFRα and ß) and fibroblast growth factor receptors (FGFR1-3) kinase activity crucial for the proliferation and survival of endothelial as well as perivascular cells, and eventually inhibiting tumour angiogenesis.
The benefits with the addition of nintedanib to docetaxel were in terms of an improvement in progression–free survival and overall survival as compared to docetaxel plus placebo.
The most common side effects are: neutropenia (including febrile neutropenia), decreased appetite, electrolyte imbalance, peripheral neuropathy, bleeding, diarrhoea, vomiting, nausea, alanine aminotransferase increase, aspartase aminotransferase increase, blood alkaline phosphatyase increase, mucositis, rash.
A pharmacovigilance plan for nintedanib will be implemented as part of the marketing authorisation.
The approved indication is:
- Nintedanib is indicated in combination with docetaxel for the treatment of adult patients with locally-advanced, metastatic or locally-recurrent NSCLC of adenocarcinoma tumour histology after first-line chemotherapy.
- It is proposed that nintedanib be prescribed by physicians experienced in the treatment of NSCLC.
- Detailed recommendations for the use of this product will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
The CHMP, on the basis of quality, safety and efficacy data submitted, considers there to be a favourable benefit-to-risk balance for nintedanib and therefore recommends the granting of the marketing authorisation.