EGFR+ Lung Cancer

David R. Gandara, MD, discusses toxicity management with the combination of dabrafenib and trametinib in non–small cell lung cancer.

A supplemental new drug application (sNDA) for alectinib (Alecensa) has been granted a priority review by the FDA for the frontline treatment of patients with <em>ALK</em>-positive locally advanced or metastatic non&ndash;small cell lung cancer (NSCLC), according to Genentech (Roche), the manufacturer of the second-generation&nbsp;ALK inhibitor.

A look back at all the FDA news that occurred in July.

ALK-Translocated Non-Small Cell Lung Cancer With Bone Metastases

During the 2017 ESMO Congress, to be held September 8-12 in Madrid, Spain, the European Society for Medical Oncology (ESMO) will award 4 oncologists with its distinguished annual awards:

Durvalumab (Imfinzi) has been granted a breakthrough therapy designation by the FDA to treat patients with locally-advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation.

Progression-free survival (PFS) was not improved with frontline durvalumab (Imfinzi), either in combination with tremelimumab or as a single agent,&nbsp;in patients with stage IV metastatic non&ndash;small cell lung cancer (NSCLC), compared with standard platinum-based chemotherapy.

Supplemental Biologics License Applications (sBLAs) were sent to and accepted by the FDA for a new dosing schedule for nivolumab (Opdivo) across all of the agent&#39;s indications as a montherapy, according to Bristol-Myers Squibb (BMS), the manufacturer of the PD-1 inhibitor.&nbsp;

The European Medicines Agency&rsquo;s Committee for Medicinal Products for Human Use (CHMP) has given its support on indications for atezolizumab (Tecentriq) in non&ndash;small cell lung cancer (NSCLC) and urothelial carcinoma.&nbsp;

Treatment of BRAF Mutated Non-Small Cell Lung Cancer