American Society of Clinical OncologyDose Optimization of Sotorasib: Is the US Food and Drug Administration Sending a Message?

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event that signals new scrutiny around determining the labeled dose for targeted oncology drugs, which still follow outdated maximum tolerated dose (MTD) principles in cytotoxic agents.

Wyanoke GroupFDA Grants Fast Track Status to Cosela for Triple-Negative Breast Cancer (TNBC)

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 […]

Everyday HealthFDA Takes Key Step Toward Banning Menthol in Cigarettes and Cigars

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 […]

Everyday HealthMedtronic’s LVAD Pulled From Market Due to Neurological, Mortality Risks

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.

American Medical AssociationAssessment of New Molecular Entities Approved for Cancer Treatment in 2020

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 […]