Year In Review | Approvals

Progress in the management of common and rare mutations among patients with advanced NSCLC continued in 2017. Starting in March and following the results of the AURA3 trail described above, the FDA approved the use of osimertinib for patients with metastatic EGFR T790M mutation-positive NSCLC who had progressed on or after another EGFR-TKI.

Then in April following the results of the ALTA trial, brigatinib was granted accelerated approval for the treatment of patients with ALK-positive NSCLC who have progressed or are otherwise intolerant to crizotinib. This was quickly followed by the approval of pembrolizumab in combination with pemetrexed and carboplatin for patients with previously untreated metastatic NSCLC in May, based on the results of KEYNOTE-021 described above.

Continuing the trend of major research leading to major approvals, ceritinib was granted regular approval for ALK-positive metastatic NSCLC based on results of the ASCEND-4 trial.

In June, a new target entered the fray, as dabrafenib and trametinib—BRAK and MEK inhibitors, respectively—were approved for patients with BRAF V600E mutation-positive metastatic NSCLC.

Then in mid-September, the first ever biosimilar approved in the U.S. for the treatment of cancer was approved. Bevacizumab-awwb, was granted approval for the same indications as reference bevacizumab, including the treatment of patients with NSCLC, metastatic CRC, metastatic RCC, and others.

Rounding out the year, alectinib was granted approval for ALK-positive metastatic NSCLC in November, based on results from the ALEX trial described herein.