J&J’s Imbruvica scores fifth FDA lymphoma approval

pharmafile | January 20, 2017 | News story | Medical Communications, Research and Development, Sales and Marketing FDA, Marginal Zone Lymphoma, imbruvica 

Johnson & Johnson’s Imbruvica (ibrutinib) has scored its fifth indication approval in the US for the treatment of Marginal Zone Lymphoma (MZL), this time in patients who require systemic therapy and have received at least one prior anti-CD20-based therapy.

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.”

Despite approvals in the US, UK regulator NICE knocked back the drug in June last year, judging that it was not cost-effective.

Matt Fellows

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