Breaking News Briefs

FDA Grants Priority Review for sBLA for Pembrolizumab

July 2, 2018—The U.S. Food and Drug Administration (FDA) granted a priority review for a supplemental biologics license application (sBLA) for pembrolizumab. The application is based on based on results of the phase III KEYNOTE-189 trial and seeks approval for pembrolizumab in combination with pemetrexed and platinum chemotherapy (carboplatin or cisplatin) as a first-line treatment for patients with metastatic NSCLC, regardless of PD-L1 expression. The FDA has set a Prescription Drug User Fee Act date of September 23, 2018.


Medicare Approves Liquid Biopsy for NSCLC

June 12, 2018—The Guardant360® assay, a liquid biopsy by Guardant Health, Inc., has been approved for all fee-for-service Medicare patients with metastatic NSCLC who meet certain criteria. Approval was based on a recent study by Odegaard et al. of 10,593 patients with advanced solid tumors that showed high feasibility (> 99.6%) and clinical sensitivity (85.9%), with high potential actionability (72% with treatment or trial recommendations). This was especially true for patients with NSCLC; 34.5% of patient samples contained a directly targetable standard-of-care biomarker.


CNDA Approves Nivolumab, China’s First PD-1 Inhibitor

June 15, 2018—the China National Drug Administration (CNDA) approved nivolumab injection for the treatment of locally advanced or metastatic NSCLC after prior platinum-based chemotherapy for patients without EGFR or ALK tumor mutations. This is China’s first and only PD-1 inhibitor. Approval was based on data from the phase III CheckMate-078 trial, in which 90% of the patients enrolled were Chinese.


ALEX Study Leads to Health Canada’s Approval of Alectinib

June 13, 2018—Health Canada approved alectinib as a monotherapy for the first-line treatment of patients with ALK-positive locally advanced (not amenable to curative therapy) or metastatic NSCLC. The approval was based on results from the phase III ALEX study, which demonstrated a reduced risk of disease progression or death by more than half (53%) with alectinib versus crizotinib. ALEX data also showed that alectinib reduced the risk of metastasis to the brain or CNS by 84% compared with crizotinib.


European Commission Grants Marketing Authorization for Osimertinib

June 8, 2018—The European Commission granted marketing authorization in early June 2018 for osimertinib as monotherapy for the first-line treatment of patients with locally-advanced or metastatic NSCLC with activating EGFR mutations. The approval is based on results from the phase III FLAURA trial.

The approval follows the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.


Crizotinib Receives Breakthrough Therapy Designation

May 29, 2018—A breakthrough therapy designation was granted to crizotinib, a kinase inhibitor, by the FDA for the treatment of patients with metastatic NSCLC with MET exon 14 alterations who experience disease progression after receiving platinum-based chemotherapy. Crizotinib is currently approved by the FDA for the treatment of patients with ALK- or ROS1-positive metastatic NSCLC.


Medtronic plc and Royal Philips Jointly Developing LungGPS™ Platform 

January 30, 2018—Medtronic plc and Royal Philips are jointly developing and marketing the LungGPS™ Patient Management Platform. The LungGPS platform is designed to make it easier for clinicians to identify and manage patients with incidental pulmonary nodules within disparate hospital information systems.

The platform uses Natural Language Processing, a type of artificial intelligence technology that quickly searches and analyzes data contained within various medical reports and highlights relevant information for further review and follow up; it also uses Philips’ Cancer Screening Solution, a software system that automates routine administrative tasks and standardizes clinical workflows for optimized efficiency and patient care.