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.
Boehringer Ingelheim has acquired all shares of ViraTherapeutics, a biopharmaceutical company specializing in the development of oncolytic viral therapies.
The European Commission has approved the Novartis agent Kymriah (tisagenlecleucel, formerly CTL019). The approved indications are for the treatment of pediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukemia that is refractory, in relapse post-transplant or in second or later relapse; and for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.
Bristol-Myers Squibb Co. said FDA accepted its supplemental Biologics License Application for Empliciti (elotuzumab) in combination with pomalidomide and low-dose dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.
