The submission is based on results from the Phase 3 E1912 study – designed and conducted by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health. The study showed significantly improved progression-free survival (PFS) and overall survival (OS) in patients treated with IMBRUVICA plus rituximab, compared to those treated with fludarabine, cyclophosphamide and rituximab (FCR). Safety data were consistent with the known safety profile of IMBRUVICA.
“While therapeutic approaches in chronic lymphocytic leukemia have improved dramatically over the past several years, chemoimmunotherapy, which can often be an aggressive course for even those who are fit enough to tolerate it, has remained a standard of care for many previously untreated patients,” said Danelle James, M.D., M.A.S., IMBRUVICA Clinical Development Lead, Pharmacyclics LLC, an AbbVie company. “We are pleased that the FDA recognizes the urgent need to bring a more efficacious treatment option to younger adult patients with CLL who are considered candidates for chemoimmunotherapy. We look forward to working closely with the agency during the review of the landmark Phase 3 E1912 clinical trial data to bring the IMBRUVICA combination regimen to younger adult patients as quickly as possible.”
The application is being reviewed under the Real-Time Oncology Review (RTOR) pilot program, which allows the FDA to review data before the applicant formally submits the complete application. The program is designed to explore a more efficient review process to ensure safe and effective treatments become available to patients earlier, while maintaining quality of review.
IMBRUVICA is a once-daily, first-in-class Bruton’s tyrosine kinase (BTK) inhibitor that is administered orally, and is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc.
Source: Company Press Release