Pharmacyclics, collaboration partner of Janssen Research & Development (Janssen), has submitted a supplemental new drug application (sNDA) for Imbruvica (ibrutinib) to the US Food and Drug Administration (FDA) for treatment of patients with chronic lymphocytic leukaemia (CLL).
The sNDA is based on data from the Phase III RESONATE study in patients with relapsed or refractory CLL, a slow-growing blood cancer of white blood cells called lymphocytes, most commonly B cells.
In February, Imbruvica secured FDA approval for treatment of patients with CLL who have received at least one prior therapy.
Approval was based on an overall response rate (ORR) from Phase II data and an improvement in survival or disease-related symptoms has not been established.
However, approval was granted under the FDA’s accelerated approval regulations and required the completion of an additional, larger Phase III trial to verify clinical benefit.
The randomised, multi-centre, open-label Phase III PCYC-1112 (RESONATE) trial compared once-daily oral Imbruvica versus intravenous ofatumumab in 391 patients with CLL or small lymphocytic lymphoma (SLL), who had received at least one prior therapy.
In January, the trial was halted on the recommendation of an independent data monitoring committee (IDMC) at the formal pre-planned interim analysis, which found Imbruvica was associated with a significant improvement in progression-free survival (the primary endpoint of the study) versus ofatumumab, and in overall survival (a major secondary endpoint of the trial).
Janssen global oncology head Peter Lebowitz said this sNDA is the first Phase III submission for Imbruvica in the US and represents a growing and more mature body of clinical evidence to support use of the drug in patients with CLL who have received prior therapy.
"We and our collaboration partner Pharmacyclics are focused on ways to bring this medicine to patients as quickly as possible and this is one more important milestone in the development of this product," Lebowitz said.
Currently, Janssen and Pharmacyclics are jointly developing and commercialising Imbruvica, which works by blocking a specific protein called Bruton’s tyrosine kinase (BTK), a major signaling molecule of the B-cell receptor signalling complex that plays a major role in the survival of malignant B cells.
Image: Wright’s stained peripheral blood smear showing chronic lymphocytic leukaemia (CLL). Photo: courtesy of Bibi Saint-Pol.