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FDA News Briefs for Monday, March 4, 2019

March 4, 2019

These Food and Drug Administration (FDA) developments came in late last week:


FDA Approves Subcutaneous Herceptin Hylecta

The FDA has approved Herceptin Hylecta (trastuzumab and hyaluronidase-oysk; Genentech Inc.) injection for subcutaneous use. Herceptin Hylecta is indicated for treatment of HER2-overexpressing breast cancer. This subcutaneous treatment includes the same monoclonal antibody as intravenous trastuzumab in combination with recombinant human hyaluronidase PH20, an enzyme that helps to deliver trastuzumab under the skin. The ready-to-use formulation can be administered in 2 to 5 minutes. More Information.


LIFEPAK 15 Recall due to Risk of Device Lockup

Physio-Control is recalling its LIFEPAK 15 Monitor/Defibrillator because the device may “lockup” (freeze) after a shock is delivered. When this occurs, the device’s monitor display goes blank and there is no response from the keypad or the device, although the device’s LED lights remain on and indicate the device still has power. Once the LIFEPAK 15 freezes, it cannot provide defibrillation therapy until the device is reset by restarting the device or removing and reinserting all connected power sources. The resulting delay in delivering a shock could and has resulted in serious patient injury including death. More Information.