Pharmacyclics Submits sNDA For Imbruvica
Pharmacyclics Inc. reported the filing of a supplemental New Drug Application (sNDA) for Imbruvica to treat mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).
Results from the RESONATE study showed a statistically significant improvement in progression-free survival in patients who received Imbruvica, the study’s primary endpoint. Participants in the trial also demonstrated statistically significant improvement in overall survival corresponding to the trial’s secondary endpoints.
Bob Duggan, CEO and chairman of the board of Pharmacyclics, said, “This supplemental new drug application in previously treated CLL patients is our first Phase 3 submission to the FDA seeking full approval for the use of Imbruvica. It is another major milestone in our clinical development plan, which currently includes 10 Phase 3 studies. Our company's mission is to serve as an ally to patients. In the RESONATE study, single agent Imbruvica provided a significant benefit for patients with CLL. We look forward to working with the FDA as they review the data from this Phase 3 study.”
Chronic lymphocytic leukemia is a slow growing blood cancer of lymphocytes, usually B-cells. The disease is the most common form of adult leukemia and has an estimated five-year survival of 82 percent. Around 16,000 patients are diagnosed with CLL in the U.S. every year.
Mantle cell lymphoma (MCL) is an aggressive type of blood cancer, specifically B-cell non-Hodgkin lymphoma (NHL). The disease typically targets the lymph nodes but can metastasize to other tissues. MCL usually occurs in older adults. Patients with MCL usually survive an average of only five years.
Imbruvica (ibrutinib) had previously received accelerated approval from the FDA as a single agent for the treatment of patients with MCL or CLL, who have received at least one prior therapy. The basis for the accelerated approval was the overall response rate of participants in a Phase II clinical study.
The company said data from the RESONATE study will be presented at the annual meeting of American Society of Clinical Oncology to be held in Chicago next month.