FDA News Briefs for Monday, March 11, 2019March 11, 2019
These Food and Drug Administration (FDA) developments came in last week:
FDA Grants Expanded Approval for Tecentriq to Treat TNBC
The FDA has granted expanded approval for Tecentriq (atezolizumab; Genentech Inc.) for use in combination with paclitaxel protein-bound for the treatment of adult patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells of any intensity covering ≥ 1% of the tumor area), as determined by an FDA approved test. This indication was approved under accelerated approval based on progression free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Tecentriq was previously approved for treatment of certain patients with urothelial carcinoma and non-small cell lung cancer. More Information.
FDA Safety Alert: Surgical Staples
The FDA issued a letter to healthcare providers regarding an increasing number of adverse events associated with surgical staplers and staples for internal use. The FDA reports that from January 1, 2011 to March 31, 2018, they received over 41,000 individual medical device reports for surgical staplers and staples for internal use, including malfunctions, serious injuries, and death. The agency has issued recommendations to help protect patient safety and reduce the risk of adverse events associated with these devices. More Information.