Industry News & Regulatory Approvals

• Everolimus (Afinitor) has been approved by the European Commission for treatment of unresectable or metastatic, well-differentiated (grade 1 or grade 2) nonfunctional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin in adults with progressive disease. Everolimus is the first approved therapy in all European Union (EU) member states, plus Iceland and Norway, for…

• Clovis Oncology is shutting down patient enrollment in clinical trials of its lung cancer drug rociletinib, which targets T790m, a mutation responsible for acquired resistance in more than half of those initially treated with firstgeneration TKIs targeting EGFR mutations. This includes the pivotal trial TIGER-3. This decision came after a US FDA panel, ODAC,…