FDA expands approval of obinutuzumab

Obinutuzumab (Gazyva)
The US Food and Drug Administration (FDA) has expanded the approved use of obinutuzumab (Gazyva®). The drug is now approved for use in combination with chemotherapy to treat patients with previously untreated follicular lymphoma (FL) that is advanced (stage II bulky, stage III, or stage IV). In patients who respond to this treatment, obinutuzumab monotherapy can be given as maintenance. The FDA granted this new approval of obinutuzumab to Genentech, Inc. The application for obinutuzumab in this indication received priority review. [Read Article]

CAR T-cell therapy on fast track with FDA, EMA

Micrograph showing
multiple myeloma
A chimeric antigen receptor (CAR) T-cell therapy, bb2121, has received breakthrough therapy designation from the US Food and Drug Administration (FDA) and was granted access to the European Medicines Agency’s (EMA’s) PRIority MEdicines (PRIME) program. The CAR T-cell therapy is designed to target B-cell maturation antigen in previously treated patients with multiple myeloma. bb2121 is being developed by bluebird bio, Inc., and Celgene Corporation. [Read Article]

Rigosertib produces better OS in MDS than tAML

Micrograph showing
myelodysplastic syndrome
Rigosertib has demonstrated activity and tolerability in patients with myelodysplastic syndromes (MDS) and acute myeloid leukemia transformed from MDS (tAML), according to researchers. In a phase 1/2 study, rigosertib produced responses in a quarter of MDS/tAML patients and enabled stable disease in another quarter. Overall survival (OS) was about a year longer for responders than for non-responders. MDS patients were more likely to respond to rigosertib and therefore enjoyed longer OS than tAML patients. [Read Article]