Don’t confirm RFK Jr. for HHS, 77 Nobel laureates urge the Senate

FDA grants accelerated approval to zenocutuzumab-zbco for NSCLC and pancreatic adenocarcinoma

FDA has granted accelerated approval to zenocutuzumab-zbco (Bizengri) for adults

December 06, 2024

Vol.50 No.45

Clinical Roundup

NCCN updates CML treatment guidelines following FDA approval of Scemblix for newly diagnosed patients

The National Comprehensive Cancer Network updated its chronic myeloid leukemia treatment guidelines, recommending Scemblix (asciminib) for the treatment of adults with newly diagnosed Ph+ CML-CP as a category 1-preferred.

FDA approves new alternative standard related to mammography report assessments

FDA recently approved Alternative Standard #25 related to the Mammography Quality Standards Act. Alternative Standard #25 allows the interpreting physician to provide an assessment of “Incomplete: Need additional imaging evaluation” for the follow-up report issued within 30 calendar days of an initial report that received an assessment of “Incomplete: Need prior mammograms for comparison.”

FDA approves revumenib for r/r acute leukemia with a KMT2A translocation

FDA approved revumenib (Revuforj, Syndax Pharmaceuticals, Inc.), a menin inhibitor, for relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients 1 year and older.

FDA approves Ziihera for HER2+ biliary tract cancer

FDA accelerated approval of Ziihera (zanidatamab-hrii) 50mg/mL for injection for intravenous use for the treatment of adults with previously treated, unresectable or metastatic HER2-positive biliary tract cancer, as detected by an FDA-approved test. Ziihera was approved under accelerated approval based on a 52% objective response rate and a median duration of response of 14.9 months as determined by independent central review. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The phase III HERIZON-BTC-302 confirmatory trial is ongoing to evaluate zanidatamab in combination with standard-of-care therapy versus standard-of-care therapy alone in the first-line setting for patients with HER2-positive BTC.