J&J's Imbruvica scores fifth FDA lymphoma approval

The drug secured accelerated approval from the FDA based on results of a Phase 2 trial which examined 63 participants suffering from all three subtypes of the illness: mucosa-associated lymphoid tissue (MALT; n=32), nodal MZL (NMZL; n=17), and splenic MZL (SMZL; n=14), and had received one prior therapy. Using criteria from the International Working Group criteria for malignant lymphoma, Imbruvica showed a 46% overall response rate (ORR); 3.2% of patients achieved complete responses and 42.9% achieved partial responses, consistent across all three subtypes.  

"Patients with relapsed/refractory marginal zone lymphoma are in critical need of treatment options to manage living with this rare, serious blood cancer," said Ariela Noy, haematologic oncologist at Memorial Sloan Kettering Cancer Center in New York. "This approval of IMBRUVICA represents a welcome new oral option for the MZL community and is the first approved therapy for these patients."