The European Medicines Agency Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the approval of trifunctional anti-CD3 x anti-EpCAM antibody Korjuny (catumaxomab) for the intraperitoneal treatment of malignant ascites in adults with EpCAM-positive carcinomas who are not eligible for further systemic anticancer therapy.
The European Medicine Agency Committee for Medicinal Products for Human Use issued positive opinions recommending an extended authorization for Tevimbra (tislelizumab) in gastric or gastroesophageal junction adenocarcinoma and esophageal squamous cell carcinoma.
EMA has accepted a Marketing Authorization Application for AVT03, a proposed biosimilar candidate to Prolia and Xgeva (denosumab).
The European Commission approved Vyloy (zolbetuximab) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin 18.2 positive.
The European Medicines Agency validated Bristol Myers Squibb’s Type II variation application for Opdivo (nivolumab) plus Yervoy (ipilimumab) as a potential first-line treatment option for adult patients with unresectable or advanced hepatocellular carcinoma who have not received prior systemic therapy.
The European Medicines Agency has accepted the marketing authorization application for Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BorDex) or pomalidomide plus dexamethasone (PomDex) as a treatment for relapsed or refractory multiple myeloma.
Patients treated with CAR T-cell medicines should be monitored life-long for secondary malignancies.
FDA and the European Medicines Agency granted an Orphan Drug Designation to Carthera for the use of carboplatin when used with SonoCloud technology in the treatment with malignant glioma.
The European Medicines Agency has validated its Type II variation application for Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with microsatellite instability–high or mismatch repair deficient metastatic colorectal cancer.
The European Medicines Agency has accepted for review the Marketing Authorization Application for odronextamab to treat adult patients with relapsed/refractory follicular lymphoma or R/R diffuse large B-cell lymphoma, who have progressed after at least two prior systemic therapies. The EMA previously granted odronextamab Orphan Drug Designation for FL and DLBCL.
