FDA granted orphan drug designation to MB-105, March Biosciences’s first-in-class CD5-targeted CAR T-cell therapy, for the treatment of relapsed/refractory CD5-positive T-cell lymphoma.
The Committee for Medicinal Products for Human Use of the European Medicines Agency recommended approval of Opdivo (nivolumab) plus Yervoy (ipilimumab) from Bristol Myers Squibb for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma, based on results from the phase III CheckMate-9DW trial. The CHMP opinion will now be reviewed by the European Commission.
CHMP recommended approval of Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor T-cell therapy, for the treatment of adult patients with relapsed or refractory follicular lymphoma who have received two or more prior lines of systemic therapy.
FDA approved AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) for the treatment of adult patients with unresectable or metastatic hormone receptor-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by the FDA approved test, that has progressed on one or more endocrine therapies in the metastatic setting.
FDA approved Grafapex (treosulfan), an alkylating agent, with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients one year of age and older with acute myeloid leukemia or myelodysplastic syndrome on Jan. 22.
Yunu and WCG announced a partnership in support of WCG’s imaging services.
FDA has accepted the Biologics License Application from Replimune Group Inc. for RP1 (vusolimogene oderparepvec) in combination with nivolumab (Opdivo) for patients with advanced melanoma.
The EU has approved Sarclisa (isatuximab-irfc) in combination with a standard-of-care regimen, bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma ineligible for autologous stem cell transplant, based on data from the IMROZ phase III study.
FDA approved sotorasib (Lumakras) with panitumumab (Vectibix) for adult patients with KRAS G12C-mutated metastatic colorectal cancer, as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
FDA approved acalabrutinib (Calquence) with bendamustine and rituximab for adults with previously untreated mantle cell lymphoma who are ineligible for autologous hematopoietic stem cell transplantation.
