• 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, voted against recommending approval. Clovis expects to receive a complete response letter from the FDA rejecting the drug. In response, the company will cut 35% of its staff by the end of 2016 and also withdraw its previously filed application with the European Medicines Agency.
• Boehringer Ingelheim’s supplemental new drug application for afatinib (Gilotrif) was approved by the US FDA for treatment of patients with advanced squamous cell carcinoma of the lung whose disease has progressed after platinum-based chemotherapy. The European Commission also approved the new indication (the drug is marketed under the product name Giotrif in Europe).
