• Alectinib (Alecensa) received full FDA approval for the first-line treatment of patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) as determined by an FDA-approved test. The approval was based on results from the phase III ALEX study that compared alectinib to crizotinib. In addition, the FDA also converted alectinib’s initial accelerated approval in December 2015 to a full approval for the treatment ALK-positive, metastatic NSCLC following disease progression on or intolerance to crizotinib (second-line). (11/06/17)
• Seribantumab (MM-121), an investigational drug candidate, received FDA orphan drug designation for the treatment of heregulin-positive NSCLC. Seribantumab is a fully human monoclonal antibody designed to block tumor survival signals and enhance the anti-tumor effect of combination therapies by targeting the cell surface receptor HER3 (ErbB3) in patients with high heregulin. (10/30/17)
• Afatinib (Gilotrif) received FDA priority review to a supplemental new drug application for the frontline treatment of patients with metastatic NSCLC whose tumors harbor EGFR exon 21 (L861Q), G719X, or S768I substitution mutations. Supplemental new drug application approval was based on data from the LUXLung 2, 3, and 6 trials in which “…afatinib showed activity in patients with NSCLC tumors that contained the more frequently reported types of uncommon EGFR mutations.” (10/10/17)
• Osimertinib (Tagrisso) received FDA breakthrough therapy designation for the first-line treatment of patients with metastatic EGFR-mutations positive NSCLC. Breakthrough therapy designation was based on data from the phase III FLAURA trial of osimertinib versus standard-of-care EGFR tyrosine kinase inhibitors in previously untreated patients with locally advanced or metastatic EGFR mutationpositive NSCLC. (10/09/17)
• Durvalumab (Imfinzi) received FDA acceptance for priority review status of supplemental biologics license application for the treatment of patients with locally advanced (stage III) unresectable NSCLC whose disease has not progressed following platinum-based chemoradiation therapy. The supplemental biologics license application was based on positive progression-free survival data from the phase III PACIFIC trial, which continues to evaluate overall survival, the other primary endpoint. (9/28/17)
• Bevacizumab-awwb (Mvasi) received FDA approval as a biosimilar to bevacizumab (Avastin) for the treatment of multiple types of cancer. Bevacizumab-awwb is the first biosimilar approved in the US for the treatment of cancer and is approved for the treatment of adult patients with certain colorectal, lung, brain, kidney and cervical cancers. For non-squamous NSCLC, the approved indication is in combination with carboplatin and paclitaxel for first-line treatment of unresectable, locally advanced, recurrent or metastatic disease. (9/14/17)
