Syndax Proclaims PDUFA Motion Date Extension for Revumenib NDA for Relapsed or Refractory KMT2Ar Acute Leukemia


– New PDUFA motion date of December 26, 2024 permits FDA extra time to finish their evaluate – 

WALTHAM, Mass., July 29, 2024 /PRNewswire/ — Syndax Prescribed drugs (Nasdaq: SNDX), a scientific stage biopharmaceutical firm growing an progressive pipeline of most cancers therapies, right now introduced that the U.S. Meals and Drug Administration (FDA) has prolonged the Prescription Drug Person Price Act (PDUFA) motion date for the New Drug Utility (NDA) for revumenib for the remedy of adults and pediatric sufferers with relapsed or refractory (R/R) KMT2Ar acute leukemia. 

The FDA notified Syndax on July 26, 2024 that they required extra time to conduct a full evaluate of supplemental data offered to the FDA in response to their requests. The submission of extra data to the FDA was decided to represent a Main Modification to the NDA and resulted in an ordinary three-month extension to the unique PDUFA motion date of September 26, 2024. No extra trials or manufacturing data have been requested by the FDA.  

“Revumenib, upon approval, would be the first drug indicated to deal with sufferers with KMT2A-rearranged acute leukemia, a inhabitants with important unmet want,” stated Michael A. Metzger, Chief Govt Officer. “We’re assured that the information from the AUGMENT-101 trial, in addition to the extra data offered to the FDA, assist approval and proceed to exhibit the significant profit revumenib brings to sufferers with this devastating illness. We look ahead to persevering with our engagement with the FDA as they full their evaluate of the NDA by December 26, 2024.”

The NDA for revumenib was granted Precedence Evaluate and is being reviewed below the FDA’s Actual-Time Oncology Evaluate (RTOR) program. The FDA beforehand granted Breakthrough Remedy, Quick Monitor and Orphan Drug designations for revumenib. 

About Revumenib
Revumenib is a potent, selective, small molecule inhibitor of the menin-KMT2A binding interplay that’s being developed for the remedy of KMT2A-rearranged (KMT2Ar), also referred to as blended lineage leukemia rearranged or MLLr, acute leukemias together with ALL and AML, and mutant nucleophosmin (mNPM1) AML. Constructive topline outcomes from the Section 2 AUGMENT-101 trial in R/R KMT2Ar acute leukemia exhibiting the trial met its major endpoint have been introduced on the sixty fifth American Society of Hematology Annual Assembly, and knowledge from the Section 1 portion of AUGMENT-101 in acute leukemia was printed in Nature. Revumenib was granted Orphan Drug Designation for the remedy of AML and ALL by the FDA and for the remedy of AML by the European Fee, and Quick Monitor designation by the FDA for the remedy of grownup and pediatric sufferers with R/R acute leukemias harboring a KMT2A rearrangement or NPM1 mutation. Revumenib was granted Breakthrough Remedy Designation by the FDA for the remedy of grownup and pediatric sufferers with R/R acute leukemia harboring a KMT2A rearrangement.

Concerning the Actual-Time Oncology Evaluate Program (RTOR)

RTOR supplies a extra environment friendly evaluate course of for oncology medication to make sure that secure and efficient remedies can be found to sufferers as early as potential, whereas bettering evaluate high quality and interesting in early iterative communication with the applicant. Particularly, it permits for shut engagement between the sponsor and the FDA all through the submission course of and it permits the FDA to evaluate particular person sections of modules of a drug software moderately than requiring the submission of full modules or a whole software previous to initiating evaluate. Extra details about RTOR will be discovered at: https://www.fda.gov/about-fda/oncology-center-excellence/real-time-oncology-review-pilot-program

About Syndax

Syndax Prescribed drugs is a scientific stage biopharmaceutical firm growing an progressive pipeline of most cancers therapies. Highlights of the Firm’s pipeline embrace revumenib, a extremely selective inhibitor of the menin–KMT2A binding interplay, and axatilimab, a monoclonal antibody that blocks the CSF-1 receptor. For extra data, please go to www.syndax.com or observe the Firm on X (previously Twitter) and LinkedIn.

Ahead-Wanting Statements

This press launch incorporates forward-looking statements inside the that means of the Personal Securities Litigation Reform Act of 1995. Phrases reminiscent of “anticipate,” “imagine,” “might,” “estimate,” “expects,” “intend,” “could,” “plan,” “potential,” “predict,” “challenge,” “ought to,” “will,” “would” or the adverse or plural of these phrases, and comparable expressions (in addition to different phrases or expressions referencing future occasions, circumstances or circumstances) are supposed to establish forward-looking statements. These forward-looking statements are based mostly on Syndax’s expectations and assumptions as of the date of this press launch. Every of those forward-looking statements entails dangers and uncertainties. Precise outcomes could differ materially from these forward-looking statements. Ahead-looking statements contained on this press launch embrace, however should not restricted to, statements in regards to the progress, timing, scientific growth and scope of scientific trials, the reporting of scientific knowledge for Syndax’s product candidates, and the potential use of its product candidates to deal with varied most cancers indications and fibrotic ailments. Many elements could trigger variations between present expectations and precise outcomes, together with: surprising security or efficacy knowledge noticed throughout preclinical or scientific trials; scientific trial web site activation or enrollment charges which might be decrease than anticipated; modifications in anticipated or current competitors; modifications within the regulatory setting; failure of Syndax’s collaborators to assist or advance collaborations or product candidates; and surprising litigation or different disputes. Different elements that will trigger Syndax’s precise outcomes to vary from these expressed or implied within the forward-looking statements on this press launch are mentioned in Syndax’s filings with the U.S. Securities and Change Fee, together with the “Threat Components” sections contained therein. Besides as required by regulation, Syndax assumes no obligation to replace any forward-looking statements contained herein to mirror any change in expectations, whilst new data turns into obtainable.

Syndax Contact

Sharon Klahre
Syndax Prescribed drugs, Inc.
sklahre@syndax.com
Tel 781.684.9827

SNDX-G

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SOURCE Syndax Prescribed drugs, Inc.



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