The application was submitted to the FDA by Novartis in March 2016 under the ofatumumab collaboration between Novartis and Genmab.
Priority Review is an FDA designation for drugs that treat serious conditions and which may provide a significant improvement in safety or efficacy compared to existing standard therapies. The FDA aims to complete its review of the ofatumumab sBLA within six months and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 10, 2016
"With the FDA’s acceptance of this sBLA, ofatumumab is one step closer to potentially benefiting an even wider population of patients than it is currently," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
"We look forward to the FDA’s feedback on this application."
The application was based on results from a Phase III study, COMPLEMENT 2, which evaluated ofatumumab in combination with FC versus FC alone in patients with relapsed CLL. Top-line results from this trial were reported in April 2015.
About CLL
CLL is the most common form of leukemia in the western world, accounting for 30% of adult leukemias. Most CLL patients experience disease progression despite initial response to therapy and may require additional treatment.
About COMPLEMENT 2
COMPLEMENT 2 (NCT00824265) is an open-label, two-arm, randomized, Phase III study, which included 365 patients in 18 countries with relapsed CLL. Patients in the study were randomized 1:1 to treatment with up to six cycles of ofatumumab in combination with fludarabine and cyclophosphamide or up to six cycles with fludarabine and cyclophosphamide alone.
The primary endpoint of the study was PFS, which was assessed by an Independent Review Committee (IRC) according to the International Workshop for Chronic Lymphocytic Leukaemia (iwCLL) updated 2008 National Cancer Institute-sponsored Working Group (NCIWG) guidelines.
The study met the primary endpoint with a median progression free survival in patients receiving ofatumumab in combination with FC of 28.9 months, compared to 18.8 months in patients receiving FC alone (HR =0.67, p=0.0032). Secondary endpoints included overall response rate, overall survival, patient reported outcomes, time to response, duration of response, time to progression, time to next therapy, safety assessments and quality of life.
About Ofatumumab (Arzerra)
Ofatumumab is a human monoclonal antibody that is designed to target the CD20 molecule found on the surface of chronic lymphocytic leukemia (CLL) cells and normal B lymphocytes.
In the United States, Arzerra is approved for use in combination with chlorambucil for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate. Arzerra is also approved as extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL in the U.S. In the European Union, Arzerra is approved for use in combination with chlorambucil or bendamustine for the treatment of patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy. In more than 50 countries worldwide, Arzerra is also indicated as monotherapy for the treatment of patients with CLL who are refractory after prior treatment with fludarabine and alemtuzumab.
Arzerra is not approved anywhere in the world in combination with fludarabine and cyclophosphamide as treatment for relapsed CLL.