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 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 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.
FDA has accepted Bayer’s supplemental new drug application for the oral androgen receptor inhibitor Nubeqa (darolutamide) in combination with androgen deprivation therapy for the treatment of patients with metastatic hormone-sensitive prostate cancer.
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.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the approval of Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. A final decision is expected in the coming months.
EC granted marketing authorization for Elahere (mirvetuximab soravtansine) for the treatment of adult patients with folate receptor-alpha positive, platinum-resistant high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior systemic treatment regimens. Elahere is the first and only folate receptor alpha-directed antibody drug conjugate medicine approved in the EU, as well as Iceland, Liechtenstein, Norway, and Northern Ireland.
Lindis Biotech GmbH announced a licensing agreement with global pharmaceutical company Pharmanovia for catumaxomab, for the treatment of malignant ascites.
ARC, the innovation arm of Sheba Medical Center Israel’s largest hospital and a global leader in clinical trials, announced today a collaboration with Roche, a leading provider of digital pathology solutions worldwide, to help improve the diagnosis and treatment of non-small cell lung cancer.
Immunai Inc. announced a multi-year collaboration with Teva Pharmaceuticals, an affiliate of Teva Pharmaceutical Industries Ltd. Under the agreement, Immunai will collaborate with Teva in immunology and Immuno-oncology programs.
