Servier today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) for TIBSOVO® (ivosidenib tablets) as a potential treatment for patients with previously untreated IDH1-mutated acute myeloid leukemia (AML). The sNDA was granted Priority Review, which accelerates the review and shortens the review time goal from 10 months to 6 months. Priority Review is typically given to drugs that may offer major advances in treatment or may provide a treatment where no adequate therapy exists.
“On the heels of our recent FDA approval of TIBSOVO in cholangiocarcinoma, we are pleased with this important step forward in the agency’s consideration to expand its current indication to include the treatment of patients with previously untreated IDH1-mutated acute myeloid leukemia,” said David K. Lee, Chief Executive Officer, Servier Pharmaceuticals. “We are thrilled with the positive momentum of this program as we continue to grow our leadership in oncology and deliver more life-changing medicines to patients living with difficult-to-treat cancers.”
The sNDA acceptance is supported by results from the AGILE study, a global, Phase 3 trial in patients with previously untreated IDH1-mutated AML, which were presented at the 2021 American Society of Hematology Annual Meeting and Exposition. The data demonstrated that treatment with TIBSOVO in combination with azacitidine significantly improved event-free survival (EFS) (hazard ratio [HR] = 0.33, 95% CI 0.16, 0.69, 1-sided P = 0.0011 1,2). In addition, the combination of TIBSOVO with azacitidine showed a statistically significant improvement in overall survival (OS) (HR = 0.44 [95% CI 0.27, 0.73]; 1-sided P = 0.0005), with a median OS of 24.0 months.
“TIBSOVO is the first therapy targeting cancer metabolism to demonstrate improved event-free survival and overall survival in combination with azacitidine in patients with previously untreated IDH1-mutated AML,” said Susan Pandya, M.D., Vice President Clinical Development and Head of Cancer Metabolism Global Development Oncology & Immuno-Oncology, Servier Pharmaceuticals. “With this FDA acceptance for Priority Review, we are closer to offering this critical treatment option to patients in the U.S. and we look forward to engaging with regulatory agencies around the world.”
TIBSOVO[*] is currently approved in the U.S. as monotherapy for the treatment of adults with IDH1-mutant relapsed or refractory acute myeloid leukemia (AML), and for adults with newly diagnosed IDH1-mutant AML who are ≥75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy. Recently, TIBSOVO was approved as a first and only targeted therapy for patients with previously treated IDH1-mutated cholangiocarcinoma.
In an effort to bring innovative treatment options to patients living with difficult-to-treat cancers, Servier has made oncology a priority globally, and allocates more than 50% of its research and development budget to cancer research. With more than 21 oncology assets at varying stages of clinical development, and 20 research projects ongoing, Servier is committed to finding solutions that address patient needs across the entire spectrum of disease and in a variety of tumor types.