The U.S. Food and Drug Administration (FDA) held a two-day public meeting to discuss managing the potential side effects of gene therapies following the death of a boy with a rare neuromuscular disease. High doses of gene therapies are known to cause liver damage, and recent studies have also found a potential long-term cancer risk […]
The FDA has required that Amgen compare its approved KRAS-targeted therapy sotorasib (Lumakras) 960-mg dose with a 240-mg dose as one of its accelerated approval post-marketing requirements, a paradigm-shifting event that signals new scrutiny around determining the labeled dose for targeted oncology drugs, which still follow outdated maximum tolerated dose (MTD) principles in cytotoxic agents.
The investigational agent – known as REGEN-COV (casirivimab and imdevimab) – was previously granted the Emergency Use Authorization (EUA) for the treatment of mild to moderate COVID-19. Now, those who are at high risk for progression to severe COVID-19, including hospitalization or death, have an option.
The additional approval expands immunization coverage to the most at-risk group for acquiring shingles – the immunocompromised. It also shortens the time to the second dose in the 2-dose Shingrix schedule. Decision support based on the Zoster Efficacy Study in Patients Undergoing HSCT (ZOE-HSCT) phase III trial (JAMA).
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 […]
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 […]
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 […]
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 […]
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 […]