– New PDUFA action date of December 26, 2024 allows FDA additional time to
complete their review –
WALTHAM,
Mass., July 29, 2024 /PRNewswire/ -- Syndax
Pharmaceuticals (Nasdaq: SNDX), a clinical stage biopharmaceutical
company developing an innovative pipeline of cancer therapies,
today announced that the U.S. Food and Drug
Administration (FDA) has extended the Prescription Drug User
Fee Act (PDUFA) action date for the New Drug Application (NDA) for
revumenib for the treatment of adults and pediatric patients with
relapsed or refractory (R/R) KMT2Ar acute leukemia.
The FDA notified Syndax on July 26,
2024 that they required additional time to conduct a full
review of supplemental information provided to the FDA in response
to their requests. The submission of additional information to the
FDA was determined to constitute a Major Amendment to the NDA and
resulted in a standard three-month extension to the original PDUFA
action date of September 26, 2024. No
additional trials or manufacturing information have been requested
by the FDA.
"Revumenib, upon approval, will be the first drug indicated to
treat patients with KMT2A-rearranged acute leukemia, a population
with significant unmet need," said Michael A. Metzger, Chief
Executive Officer. "We are confident that the data from the
AUGMENT-101 trial, as well as the additional information provided
to the FDA, support approval and continue to demonstrate the
meaningful benefit revumenib brings to patients with this
devastating disease. We look forward to continuing our engagement
with the FDA as they complete their review of the NDA by
December 26, 2024."
The NDA for revumenib was granted Priority Review and is being
reviewed under the FDA's Real-Time Oncology Review (RTOR) program.
The FDA previously granted Breakthrough Therapy, Fast Track and
Orphan Drug designations for revumenib.
About Revumenib
Revumenib is a potent, selective,
small molecule inhibitor of the menin-KMT2A binding interaction
that is being developed for the treatment of KMT2A-rearranged
(KMT2Ar), also known as mixed lineage leukemia rearranged or MLLr,
acute leukemias including ALL and AML, and mutant nucleophosmin
(mNPM1) AML. Positive topline results from the Phase 2 AUGMENT-101
trial in R/R KMT2Ar acute leukemia showing the trial met its
primary endpoint were presented at the 65th American Society of
Hematology Annual Meeting, and data from the Phase 1 portion of
AUGMENT-101 in acute leukemia was published in Nature. Revumenib
was granted Orphan Drug Designation for the treatment of AML and
ALL by the FDA and for the treatment of AML by the European
Commission, and Fast Track designation by the FDA for the treatment
of adult and pediatric patients with R/R acute leukemias harboring
a KMT2A rearrangement or NPM1 mutation. Revumenib was granted
Breakthrough Therapy Designation by the FDA for the treatment of
adult and pediatric patients with R/R acute leukemia harboring a
KMT2A rearrangement.
About the Real-Time Oncology Review Program
(RTOR)
RTOR provides a more efficient review process for oncology drugs
to ensure that safe and effective treatments are available to
patients as early as possible, while improving review quality and
engaging in early iterative communication with the applicant.
Specifically, it allows for close engagement between the sponsor
and the FDA throughout the submission process and it enables the
FDA to review individual sections of modules of a drug application
rather than requiring the submission of complete modules or a
complete application prior to initiating review. Additional
information about RTOR can be found at:
https://www.fda.gov/about-fda/oncology-center-excellence/real-time-oncology-review-pilot-program
About Syndax
Syndax Pharmaceuticals is a clinical stage biopharmaceutical
company developing an innovative pipeline of cancer therapies.
Highlights of the Company's pipeline include revumenib, a highly
selective inhibitor of the menin–KMT2A binding interaction, and
axatilimab, a monoclonal antibody that blocks the CSF-1 receptor.
For more information, please visit www.syndax.com or
follow the Company on X (formerly
Twitter) and LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Words such as "anticipate," "believe," "could," "estimate,"
"expects," "intend," "may," "plan," "potential," "predict,"
"project," "should," "will," "would" or the negative or plural of
those terms, and similar expressions (as well as other words or
expressions referencing future events, conditions or circumstances)
are intended to identify forward-looking statements. These
forward-looking statements are based on Syndax's expectations and
assumptions as of the date of this press release. Each of these
forward-looking statements involves risks and uncertainties. Actual
results may differ materially from these forward-looking
statements. Forward-looking statements contained in this press
release include, but are not limited to, statements about the
progress, timing, clinical development and scope of clinical
trials, the reporting of clinical data for Syndax's product
candidates, and the potential use of its product candidates to
treat various cancer indications and fibrotic diseases. Many
factors may cause differences between current expectations and
actual results, including: unexpected safety or efficacy data
observed during preclinical or clinical trials; clinical trial site
activation or enrollment rates that are lower than expected;
changes in expected or existing competition; changes in the
regulatory environment; failure of Syndax's collaborators to
support or advance collaborations or product candidates; and
unexpected litigation or other disputes. Other factors that may
cause Syndax's actual results to differ from those expressed or
implied in the forward-looking statements in this press release are
discussed in Syndax's filings with the U.S. Securities and Exchange
Commission, including the "Risk Factors" sections contained
therein. Except as required by law, Syndax assumes no obligation to
update any forward-looking statements contained herein to reflect
any change in expectations, even as new information becomes
available.
Syndax Contact
Sharon Klahre
Syndax Pharmaceuticals, Inc.
sklahre@syndax.com
Tel 781.684.9827
SNDX-G
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SOURCE Syndax Pharmaceuticals, Inc.