Articles related to FDA

The action comes after observational evidence associating the HeartWare left ventricular assist device (LVAD) with increased neurological adverse events and mortality, as well as more than 100 complaints involving delay or failure to restart. First approved in November 2012, the LVAD has been implanted in approximately 2,000 US patients experiencing end-stage heart failure.

Despite the pandemic interrupting trials and drug development in 2020, the US Food and Drug Administration (FDA) claims it is “full speed ahead” on the approval of novel cancer drug therapies. The authors of this Journal of the American Medical Association (JAMA) study wanted to verify these remarks, reviewing the FDA Hematology/Oncology Approvals website to ascertain all hematology/oncology drugs approved in 2020.

This article dives into information and the causes of five drug-induced diseases (DIDs) including hyponatremia/SIADH, pulmonary disease, GI bleeding, QT prolongation/Torsades de pointes, and hypoglycemia. Because research reviewed by the FDA for drug approval does not always include DIDs, it is the physician’s responsibility to monitor for DIDs and think twice about prescribing agents that could lead to DIDs.

This article from the American College of Physicians (ACP) provides a deeper dive into the pause of the J&J vaccine, which was recommended by the FDA and CDC on April 13, 2021, after six cases of cerebral venous sinus thrombosis (CVST) among patients who had received the vaccine was reported. The pause is being done to determine whether the vaccine is associated with any other types of thrombosis and to develop more specific recommendations for its use, possibly based on age.

This new indication marks the second FDA approval for sacituzumab govitecan (Trodelvy, Immunomedics) and was based on the phase 2, single-arm TROPHY-U-01 main efficacy endpoints in objective response rate (ORR) and duration of response (DOR). With a relative 5-year survival rate of 5.5%, this is a significant advancement for patients with metastatic urothelial cancer (mUC), the most common type of bladder cancer.

The approval of the new cetuximab (Erbitux) dosage – 500 mg/m2 as a two-hour IV infusion every two weeks – was based on population pharmacokinetic (PK) modeling analyses and provides an alternative option to the previously approved weekly dose. Cetuximab can be dosed alone or in combination with chemotherapy.