Industry News & Regulatory Approvals

• Alectinib received FDA priority review designation for first-line treatment of patients with ALK-positive, locally advanced or metastatic NSCLC. The supplemental new drug application included results from the phase III […]

• Dabrafenib and trametidnib (Tafinlar and Mekinist) received FDA approval for use in combination for patients with metastatic non-small cell lung cancer (NSCLC) with BRAFV600E mutation as detected by an […]

• Pembrolizumab (Keytruda) received FDA approval for use in combination with pemetrexed and carboplatin for the first-line treatment of patients with metastatic nonsquamous NSCLC, irrespective of PD-L1 expression. This approval […]

• The global, randomized phase III ALEX study was announced to have met its primary endpoint, demonstrating that alectinib (Alecensa), as an initial (first-line) treatment, significantly reduced the risk of […]

Alectinib (Alecensa) received a positive opinion from the European Medicines Agency (EMA) for Medicinal Products for Human Use (CHMP) for the treatment of adult patients with advanced anaplastic lymphoma kinase […]

RECENT APPROVALS: Pembrolizumab (Keytruda) was approved by the FDA for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1. The following indications for pembrolizumab […]

• 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 […]

• 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 […]