FDA Extends Review of Syndax's Revumenib by 3 Months Due to Data Request

Syndax Pharmaceuticals has encountered a three-month delay in obtaining approval for its drug revumenib, intended for patients with relapsed or refractory (R/R) KMT2A-rearranged acute leukemia. This delay follows a request from the U.S. Food and Drug Administration (FDA) for additional time to review the company's application. The new target date for the FDA's decision is now set for December 26, extended from the original deadline of September 26.

The FDA's request for more time stems from the need to thoroughly evaluate supplemental information that Syndax provided in response to the agency's queries. The submission of this extra data was classified by the FDA as a major amendment to the original filing, thereby necessitating a standard three-month review extension. Despite the setback, the company highlighted that the FDA has not asked for any further clinical trials or additional manufacturing information.

Syndax's shares took a hit on the stock market, dropping nearly 13% following the announcement on Monday. Despite this, CEO Michael Metzger expressed confidence in the robustness of the data from the AUGMENT-101 trial and the additional information submitted to the FDA, affirming that they collectively support the drug's approval.

Revumenib is a selective, small-molecule inhibitor targeting the menin-KMT2A binding interaction. It is being developed to treat KMT2A-rearranged acute leukemias, which include acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML), as well as mutant nucleophosmin AML.