FDA granted priority review for Imfinzi (durvalumab), AstraZeneca’s supplemental Biologics License Application, based on the results from the positive ADRIATIC phase III trial in patients with limited-stage small cell lung cancer whose disease has not progressed following platinum-based concurrent chemoradiotherapy.
The National Comprehensive Cancer Network added Lymphir (denileukin diftitox-cxdl), a novel immunotherapy for the treatment of relapsed or refractory cutaneous T-cell lymphoma after at least one prior systemic therapy, to the NCCN Clinical Practice Guidelines in Oncology. Lymphir is included based on an NCCN Category 2A recommendation which indicates a uniform NCCN consensus that the drug is appropriate as an option for patients with CTCL.
The European Commission approved Padcev (enfortumab vedotin) in combination with Keytruda (pembrolizumab) for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer, who are eligible for platinum-containing chemotherapy.
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.
