FDA Grants Approval of Agios’ Pharmaceuticals’ TIBSOVO®

Agios Pharmaceuticals (NASDAQ:AGIO) has announced that TIBSOVO was granted approval from the US Food and Drug Administration (FDA) for treatment of adult patients with relapsed or refractory acute myeloid leukemia.

As quoted in the press release:

TIBSOVO^®, an oral, targeted inhibitor of the IDH1 enzyme, is the first and only FDA-approved therapy for patients with R/R AML and an IDH1 mutation¹.

“The FDA approval of TIBSOVO^® – our first wholly owned drug and the second approved medicine from our research platform in less than a year – is an incredibly exciting milestone for our company and, importantly, for the approximately 6-10% of AML patients with an IDH1 mutation who have been waiting for new treatment options that work radically different than conventional chemotherapy,” said David Schenkein, M.D., chief executive officer at Agios. “I want to thank the patients and their caregivers, nurses and physicians who participated in our clinical trials. With their support and the dedication of Agios’ employees, we are well on our way to becoming a sustainable multi-product biopharmaceutical company delivering medicines that have the potential to change how serious diseases are treated.”

AML is a cancer of the blood and bone marrow marked by rapid disease progression and is the most common acute leukemia affecting adults with approximately 20,000 new cases estimated in the U.S. each year.^3,4 The majority of patients with AML eventually relapse. Relapsed or refractory AML has a poor prognosis.⁵ The five-year survival rate is approximately 27%.³ For 6 to 10 percent of AML patients, the mutated IDH1 enzyme blocks normal blood stem cell differentiation, contributing to the genesis of acute leukemia.²

Click here to read the full press release.