FDA accepts sNDA for prostate cancer treatment

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.

November 22, 2024

Vol.50 No.44

Drugs & Targets

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.”

November 22, 2024

Vol.50 No.44

Drugs & Targets

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.

November 22, 2024

Vol.50 No.44

Drugs & Targets

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.

November 22, 2024

Vol.50 No.44

Drugs & Targets

FDA approves first companion diagnostic for lung cancer drug

FDA has approved FoundationOne Liquid CDx to be used as a companion diagnostic for Tepmetko (tepotinib) developed by EMD Serono, the healthcare business of Merck KGaA, Darmstadt, Germany in the U.S. and Canada. Tepmetko received accelerated approval from FDA in February 2021 and traditional approval in February 2024 for the treatment of adult patients with metastatic non-small cell lung cancer harboring mesenchymal-epithelial transition exon 14 skipping alterations. FoundationOne Liquid CDx is the first FDA-approved companion diagnostic to identify patients who may be eligible for Tepmetko.

November 22, 2024

Vol.50 No.44