The FDA approves Glaxo (GSK) and Genmab's (GNMSF) monoclonal antibody Arzerra (ofatumumab) as a first-line therapy for patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate.
"Arzerra is the only therapeutic CD20 antibody approved in combination with chlorambucil for first-line CLL and as a monotherapy for CLL refractory to fludarabine and alemtuzumab," says Jan de Winkel, Ph.D., Genmab's CEO.
In the Phase 3 COMPLEMENT 1 clinical trial the ofatumumab plus chlorambucil group's progression-free survival (PFS) was 22.4 months compared to 13.1 months for the chlorambucil alone group.
GlaxoSmithKline (GSK -3%) says a combination of ARZERRA and chlorambucil has met its primary endpoint of improving progression free survival times (versus treatment with chlorambucil alone) in a pivotal Phase 3 trial with partner Genmab (GNMSF.PK). No unexpected safety issues were encountered. (PR)
J&J (JNJ) unit Janssen Biotech buys the global licensing rights to cancer agent daratumumab from Danish biotech Genmab in a deal that could eventually be worth over $1.1B. Janssen is paying $55M upfront and will make further payments following the achievement of development, regulatory and sales milestones. J&J is also investing $80M in Genmab in return for a 10.7% stake. (PR)