Blinatumomab granted full approval to treat rel/ref BCP-ALL



Vials of blinatumomab
powder and solution
Photo courtesy of Amgen
The US Food and Drug Administration (FDA) has approved the supplemental biologics license application (sBLA) for blinatumomab (Blincyto®). The aim of the sBLA was to expand the indication for blinatumomab to include all patients with relapsed or refractory B-cell precursor acute lymphoblastic... [Read Article]

Vaccine granted orphan designation for MDS



Micrograph showing MDS
The US Food and Drug Administration (FDA) has granted orphan drug designation to DSP-7888, an investigational cancer peptide vaccine, for the treatment of myelodysplastic syndromes (MDS). DSP-7888 contains peptides to induce Wilms' tumor gene 1 (WT1)-specific cytotoxic T lymphocytes and helper T cells, which attack WT1-expressing cancerous cells found in... [Read Article]

FDA puts pembrolizumab trials on clinical hold



Pembrolizumab (Keytruda)
Photo courtesy of Merck
The US Food and Drug Administration (FDA) has placed clinical holds on 3 trials testing combination therapy with pembrolizumab (Keytruda) in patients with multiple myeloma (MM)—KEYNOTE-183, KEYNOTE-185, and KEYNOTE-023. In 2 of these trials—KEYNOTE-183 and -185—there were more deaths among patients receiving pembrolizumab than among patients receiving... [Read Article]

EC approves therapy for relapsed/refractory BCP-ALL



BCP-ALL
The European Commission (EC) has approved inotuzumab ozogamicin (BESPONSA®) as monotherapy for adults with relapsed or refractory, CD22-positive B-cell precursor acute lymphoblastic leukemia (BCP-ALL). Adults with Philadelphia chromosome-positive, relapsed/refractory, CD22-positive BCP-ALL should have failed treatment with at least one tyrosine kinase inhibitor before receiving inotuzumab ozogamicin. Inotuzumab ozogamicin is an antibody-drug conjugate... [Read Article]