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A look back at all the FDA news in oncology from the month of February 2019, including several new approvals, priority review designations, and an orphan drug desgination.

Guardant360—a 73-gene next-generation sequencing panel—detected all of the guideline-recommended biomarkers in patients newly diagnosed with metastatic non–small cell lung cancer at a similar rate, but in a faster turnaround time than tissue genotyping, according to data from the NILE study.






Stage IIIA Unresectable NSCLC After Chemoradiotherapy

Pembrolizumab has been granted a priority review designation by the FDA for the treatment of patients with advanced small cell lung cancer whose disease has progressed following ≥2 prior lines of therapy.

Entrectinib has been granted a priority review designation by the FDA as a therapy for select adult and pediatric patients with <em>NTRK</em> fusion–positive locally advanced or metastatic solid tumors, as well as patients with metastatic <em>ROS1</em>-positive non–small cell lung cancer, according to Genentech, the developer of the multikinase inhibitor.









Edward B. Garon, MD, discussed these data, as well as other trials investigating immunotherapeutic agents for patients with EGFR-mutant non–small cell lung cancer.

In a presentation during the 2nd Annual Precision Medicine Through Plasma: Using Liquid Biopsies in Contemporary Oncology Care symposium, Bob T. Li, MD, MPH, explained ctDNA’s growing importance in lung cancer, given the disease’s challenging prognosis.

Liquid biopsies have evolved beyond finding genotypes and have moved into the cancer detection and monitoring spaces, according to Geoffrey R. Oxnard, MD, medical oncologist at the Dana-Farber Cancer Institute and associate professor of medicine at Harvard Medical School.

Rogerio Lilenbaum, MD, highlights the current treatment approaches for patients with <em>EGFR</em>-positive NSCLC and sheds light on the potential for immunotherapy in the space.

Edward B. Garon, MD, discusses data from the IMpower150 trial where patients with <em>EGFR-</em>mutant lung cancer were randomized to 1 of 3 arms: a control of carboplatin, paclitaxel, and bevacizumab (Avastin), an arm replacing bevacizumab with atezolizumab (Tecentriq), and a third using all 4 agents.

A look back at all the FDA news in oncology from the month of January 2019, including several new approvals, breakthrough therapy designations, and a partial clinical hold.

Sukhmani Padda, MD, discusses how third-generation tyrosine kinase inhibitors compare to the first- and second-generation TKIs.



































