FDA approved Opdivo (nivolumab) with platinum-doublet chemotherapy for adult patients with resectable non-small cell lung cancer in the neoadjuvant setting.
FDA accepted a supplemental New Drug Application for Tibsovo (ivosidenib tablets) as a potential treatment for patients with previously untreated IDH1-mutated acute myeloid leukemia. The sNDA was granted priority review.
FDA issued three final guidances to industry regarding cancer clinical trials that parallel the goals of President Biden’s recently announced effort to renew and build upon his 2016 Cancer Moonshot initiative to facilitate continued advancement in cancer prevention, detection, research, and patient care (The Cancer Letter, Feb. 4, 2022).Â
Wednesday, March 8, marks six months since FDA failed to meet its court-ordered deadline to rule on all e-cigarette and other new tobacco product manufacturers’ applications.Â
The U.S, Senate Feb. 15 voted 50-46 to confirm Robert Califf as the next commissioner of FDA.
FDAÂ granted Fast Track designation for IO-202, a first-in-class myeloid checkpoint inhibitor targeting leukocyte immunoglobulin-like receptor B4 (LILRB4, also known as ILT3) for the treatment of patients with relapsed or refractory acute myeloid leukemia.Â
In a 14:1 vote, ODAC nixes a PD-1 drug developed in China; data not generalizable to U.S. population
The FDA Oncologic Drugs Advisory Committee expressed decisive support for the agency’s view that data from trials of checkpoint inhibitors performed in mainland China aren’t applicable to the U.S. population.
FDA is preparing to review an estimated 25 applications for cancer drugs that are being developed based largely—and in many cases entirely—on data from mainland China.
FDA is investigating a possible increased risk of death with the drug Ukoniq (umbralisib) approved to treat relapsed or refractory marginal zone lymphoma.Â
The Senate Health, Education, Labor, and Pension Committee voted 13-8 to confirm Robert Califf as the next commissioner of FDA. Next, Califf’s candidacy goes to the full Senate.
