J&J/AbbVie blood cancer drug gets fifth US indication

The FDA has approved Johnson & Johnson/AbbVie’s Imbruvica pill in a fifth blood cancer use.

Imbruvica is a key drug for both companies – they split the profits from the drug after AbbVie bought J&J’s development partner, Pharmacyclics, in 2015 – with sales expected to peak well into the billions.

Imbruvica's (ibrutinib) new approval is for marginal zone lymphoma (MZL) patients who require system therapy and have received at least one prior anti-CD20-based therapy.

This is an accelerated approval, based upon overall response rate data, and the companies must provide confirmatory trial data to ensure the drug can stay on the market in this indication in the long term.

MZL is a slow-growing B-cell lymphoma occurring in white blood cells at the edges of lymph nodes and various tissues, including the stomach, salivary glands, thyroid gland, eyes, lungs and spleen.

It accounts for around 12% of all cases of non-Hodgkin’s lymphoma in adults.

The drug's approval was based on phase 2 data from the PCYC-1121 trial assessing safety and efficacy of Imbruvica in 63 patients with MZL, who received at least one prior therapy, including all three subtypes – mucosa associated lymphoid tissues (MALT), nodal MZL and splenic MZL.

Overall response rate was 46.9%, 41,2% and 50% for MALT, nodal, and splenic subtypes, respectively.

Ariela Noy, haematologic oncologist at Memorial Sloan Kettering Cancer Center in New York and lead investigator of the study, said: “Patients with relapsed/refractory marginal zone lymphoma are in critical need of treatment options to manage living with this rare, serious blood cancer.”

“This approval of Imbruvica represents a welcome new oral option for the MZL community and is the first approved therapy for these patients.”