FDA grants Servier approval for new indication of Tibsovo
Servier, a leader in oncology, has received the Food and Drug Administration’s blessing for Tibsovo (ivosidenib tablets) in combination with azacitidine for the treatment of patients with newly diagnosed IDH1-mutated acute myeloid leukemia in adults aged 75 years old or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
Tibsovo also is approved as monotherapy for the treatment of adults with IDH1-mutant relapsed or refractory AML, and for adults with newly diagnosed IDH1-mutated AML who are greater than the age of 75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy. Last year, Tibsovo garnered its first approval in a non-hematologic malignancy for patients with previously treated IDH1-mutated cholangiocarcinoma.
"Today's approval builds on the established body of evidence for Tibsovo, which is now approved across multiple IDH1-mutated cancer types," said David Lee, CEO of Servier. "As a leader in oncology pioneering the science behind targeted IDH inhibition, we are proud to bring a new therapeutic option to the acute myeloid leukemia community and remain committed to pushing the boundaries of healthcare innovation in oncology and beyond."
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Tibsovo is the first therapy targeting cancer metabolism approved in combination with azacitidine for patients with newly diagnosed IDH1-mutated AML, the company said.
Acute myeloid leukemia, a cancer of blood and bone marrow characterized by rapid disease progression, is the most common acute leukemia affecting adults, with approximately 20,000 new cases in the United States. AML incidence significantly increases with age, and the median age of diagnosis is 68.2. The five-year survival rate is approximately 29.5%. For 6% to 10% of AML patients, the mutated IDH1 enzyme blocks normal blood stem cell differentiation, contributing to the genesis of acute leukemia.
"Acute myeloid leukemia is a rapidly progressing, difficult-to-treat blood cancer with a poor prognosis," said Eytan Stein, director of the program for drug development in leukemia, Leukemia Service at the department of Medicine at Memorial Sloan Kettering Cancer Center. "In addition to a favorable safety profile, Tibsovo is the first therapy targeting cancer metabolism to demonstrate an impressive, significant benefit in event-free survival and overall survival in combination with azacitidine, underscoring its importance as part of a new combination regimen for patients with newly diagnosed IDH1-mutated acute myeloid leukemia who are not candidates for intensive induction chemotherapy."
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The recommended dosage of Tibsovo for newly diagnosed IDH1-mutated AML is 500 mg once daily via oral administration, the company said.
"People living with acute myeloid leukemia, especially those who are newly diagnosed and are not eligible for intensive chemotherapy, have had few treatment options," said Susan Pandya, vice president of clinical development and head of cancer metabolism global development oncology and immuno-oncology at Servier. "Today's approval of Tibsovo in combination with azacitidine represents a major advancement for patients with newly diagnosed IDH1-mutated acute myeloid leukemia in the United States, and we look forward to continuing our engagement with regulatory authorities worldwide."
In an effort to support the patient communities it serves, Servier recently introduced ServierONE Patient Support Services, a program that offers one-on-one support to help patients who are prescribed Tibsovo or other Servier products navigate their cancer journey. Eligible patients will have access to financial assistance, emotional support and other resources.