Articles related to FDA

Trilaciclib (Cosela, G1 Therapeutics), a cyclin dependent kinase 4/6 inhibitor, is already approved in the United States to reduce frequency of chemotherapy-related bone marrow suppression among adults with extensive-stage small cell lung cancer. Now, the FDA has granted fast track designation to the drug for use in combo with chemo for treatment of locally advanced or metastatic TNBC.

The FDA added a warning that Johnson & Johnson’s COVID-19 vaccine may trigger Guillain-Barré syndrome (GBS) in a small number of people. Of the 12.5 million Americans who received this vaccine, about 100 people reported having GBS, which is an acquired demyelinating polyneuropathy that often begins in the lower extremities and ascends over time with loss of reflexes, causing muscle weakness, or in the most severe cases, paralysis.

According to a press release from April 2021, “the FDA is working toward issuing proposed product standards within the next year to ban menthol as a characterizing flavor in cigarettes and ban all characterizing flavors (including menthol) in cigars.” Acting Commissioner Janet Woodcock, MD, said the agency had now “accumulated sufficient evidence establishing the addictiveness and harm from menthol,” which provides a “trajectory” toward ending tobacco-related disease and death.

The investigational new drug (IND) application is for GDX012, which also received an FDA orphan drug designation for the treatment of acute myeloid leukemia (AML). The drug’s manufacturer, GammaDelta Therapeutics, is developing the T-cell platform in partnership with Takeda and will initiate a phase I study in late 2021 that will evaluate the treatment’s safety and activity in patients with measurable residual disease-positive AML.

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.