The European Commission approved Ordspono (odronextamab) to treat adult patients with relapsed or refractory follicular lymphoma or r/r diffuse large B-cell lymphoma, after two or more lines of systemic therapy. Ordspono is a bispecific antibody that acts by linking the lymphoma cell to a killer T cell.
The European Commission approved Imfinzi (durvalumab) and Lynparza (olaparib) as treatment for certain patients with primary advanced or recurrent endometrial cancer. Imfinzi plus chemotherapy as first-line treatment followed by Lynparza and Imfinzi has been approved for patients with mismatch repair proficient disease. Imfinzi plus chemotherapy followed by Imfinzi alone has been approved for patients with mismatch repair deficient disease.
The European Commission granted conditional marketing authorization for Tepkinly (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of prior therapy. Tepkinly is the only subcutaneous T-cell engaging bispecific antibody approved to treat both r/r FL and r/r diffuse large B-cell lymphoma in the EU, as well as the European Economic Area countries (Iceland, Liechtenstein, Norway) and Northern Ireland.
FDA has approved Voranigo (vorasidenib), an isocitrate dehydrogenase-1 and isocitrate dehydrogenase-2 inhibitor, for the treatment of adult and pediatric patients 12 years and older with grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, sub-total resection, or gross total resection.
FDA has approved Lymphir (denileukin diftitox-cxdl), a novel immunotherapy for the treatment of r/r cutaneous T-cell lymphoma after at least one prior systemic therapy.
Labcorp announced it has received de novo marketing authorization from FDA for PGDx elio plasma focus Dx—the industry’s first and only kitted, pan-solid tumor liquid biopsy test.
Daiichi Sankyo and Merck have expanded their existing global co-development and co-commercialization agreement for three investigational DXd antibody-drug conjugates to include Merck’s MK-6070, an investigational delta-like ligand 3 targeting T-cell engager.
FDA has granted an accelerated approval to afamitresgene autoleucel (Tecelra), a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T-cell immunotherapy, for adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices.
FDA has approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomid, and dexamethasone (D-VRd) for induction and consolidation in patients with newly-diagnosed multiple myeloma who are eligible for an autologous stem cell transplant.
Guardant Health Inc., a precision oncology company, announced that FDA has approved the company’s Shield blood test for colorectal cancer screening in adults age 45 and older who are at average risk for the disease.
