FDA has permitted marketing of ClonoSEQ assay, a next generation sequencing-based test for minimal residual disease in patients with acute lymphoblastic leukemia or multiple myeloma.
FDA has approved Libtayo (cemiplimab-rwlc) for the treatment of patients with metastatic cutaneous squamous cell carcinoma or locally advanced CSCC who are not candidates for curative surgery or curative radiation.
FDA has approved Vizimpro (dacomitinib), a kinase inhibitor for the first-line treatment of patients with metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.
FDA has approved Copiktra (duvelisib), an oral inhibitor of phosphoinositide 3-kinase and the first approved dual inhibitor of PI3K-delta and PI3K-gamma. Copiktra is approved for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma after at least two prior therapies.
FDA has granted Qualified Infectious Disease Product and Fast Track designations for the company's prophylaxis development program for its lead antifungal product candidate, rezafungin for injection.
Japanese Ministry of Health, Labour and Welfare has granted marketing approval for Blincyto (blinatumomab) for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia. Blincyto was developed in Japan by Amgen Astellas BioPharma K.K., a joint venture between Amgen and Astellas Pharma Inc., a pharmaceutical company headquartered in Tokyo.
The European Commission has granted marketing authorization to Udenyca (formerly CHS-1701), a pegfilgrastim (Neulasta) biosimilar. Udenyca is one of the first pegfilgrastim biosimilars to gain marketing authorization in Europe.
European Commission has approved Braftovi in combination with Mektovi for the treatment of adult patients with unresectable or metastatic melanoma with a BRAFV600 mutation, as detected by a validated test. This approval is applicable to all 28 European Union member states, as well as Liechtenstein, Iceland and Norway.
OBI Pharma, Inc., a Taiwan biopharma company, announced that FDA has granted Orphan Drug Designation for OBI-3424 for the treatment of acute lymphoblastic leukemia.
FDA has approved AstraZeneca's moxetumomab pasudotox-tdfk, a CD22-directed cytotoxin indicated for adult patients with relapsed or refractory hairy cell leukemia who received at least two prior systemic therapies, including treatment with a purine nucleoside analog.