Syros Receives Fast Track Designation from the FDA for Tamibarotene for the Treatment of Newly Diagnosed Unfit AML with RARA gene overexpression
April 09 2024 - 7:00AM
Business Wire
Syros Pharmaceuticals (NASDAQ:SYRS), a biopharmaceutical company
committed to advancing new standards of care for the frontline
treatment of hematologic malignancies, today announced that the
United States Food and Drug Administration (FDA) has granted Fast
Track Designation to tamibarotene in combination with azacitidine
and venetoclax for the treatment of newly diagnosed acute myeloid
leukemia (AML) with RARA overexpression as detected by an FDA
approved test in adults who are over age 75 years or who have
comorbidities that preclude the use of intensive induction
chemotherapy. Tamibarotene, an oral first-in-class selective
retinoic acid receptor alpha (RARα) agonist, is currently being
evaluated in combination with venetoclax and azacitidine for the
treatment of newly diagnosed AML patients with RARA gene
overexpression.
“We are pleased to receive Fast Track designation for
tamibarotene for the treatment of AML. This designation reflects
the tremendous need for a safe and effective therapy, which can
improve the clinical outcomes and prognosis among people diagnosed
with AML, many of whom cannot tolerate intensive treatment,” said
David A. Roth, M.D., Chief Medical Officer of Syros
Pharmaceuticals. “We are particularly encouraged to secure Fast
Track designation following initial randomized data from a
prespecified interim analysis of our ongoing SELECT-AML-1 clinical
trial, in which treatment with our RARα agonist, tamibarotene, in
combination with venetoclax and azacitidine resulted in a 100%
CR/CRi rate compared with a 70% CR/CRi rate for the comparator of
venetoclax and azacitidine. Additionally, tamibarotene in
combination with venetoclax and azacitidine demonstrated no added
toxicity relative to venetoclax and azacitidine alone. We look
forward to sharing additional data from SELECT-AML-1 later this
year, and to potentially accelerate the delivery of tamibarotene as
a new frontline option for the approximately 30% of AML patients
who are positive for RARA overexpression.”
Fast Track is a process designed by the FDA to facilitate the
development and expedite the review of drug candidates intended to
treat serious conditions and for which nonclinical or clinical data
demonstrate the potential to address unmet medical need. The
purpose is to facilitate development and expedite review of drugs
to treat serious and life-threatening conditions, to bring the
approved products to patients earlier. A therapeutic candidate that
receives Fast Track designation may be eligible for more frequent
interactions with the FDA to discuss the therapeutic candidate’s
development plan. Therapeutic candidates with Fast Track
designation may also be eligible for priority review and
accelerated approval if supported by clinical data.
Syros is evaluating tamibarotene in combination with venetoclax
and azacitidine in newly diagnosed, unfit AML patients with RARA
overexpression in the ongoing SELECT-AML-1 Phase 2 trial. In
December 2023, Syros announced initial randomized data from
SELECT-AML-1, demonstrating a 100% CR/CRi (complete
response/complete response with incomplete hematologic recovery)
rate in response-evaluable patients (nine of nine) treated with the
triplet regimen of tamibarotene, venetoclax and azacitidine, as
compared to 70% among patients (seven of ten) treated with
venetoclax and azacitidine alone, with corresponding CR rates of
78% vs 30%, respectively. The median time to CR/CRi response was
rapid; all patients treated with the triplet regimen achieved a
CR/CRi by the end of cycle one. Consistent with prior clinical
experience, tamibarotene in combination with approved doses of
venetoclax and azacitidine was generally well tolerated, and the
overall safety profile demonstrated no additive toxicities or new
safety signals, and no evidence of increased myelosuppression
compared to treatment with the doublet combination of venetoclax
and azacitidine. Syros expects to report additional data from
SELECT-AML-1 in 2024.
Syros is also evaluating tamibarotene in combination with
azacitidine in newly diagnosed higher-risk myelodysplastic syndrome
(MDS) patients with RARA overexpression in the SELECT-MDS-1 Phase 3
trial. As recently announced, enrollment to support the pivotal
primary efficacy analysis was completed in the first quarter of
2024, and pivotal complete response data is expected by the middle
of the fourth quarter of 2024. In January 2023, the FDA granted
Fast Track Designation to tamibarotene for the treatment of HR-MDS
patients with RARA overexpression.
About Syros Pharmaceuticals Syros is committed to
developing new standards of care for the frontline treatment of
patients with hematologic malignancies. Driven by the motivation to
help patients with blood disorders that have largely eluded other
targeted approaches, Syros is developing tamibarotene, an oral
selective RARα agonist in frontline patients with higher-risk
myelodysplastic syndrome and acute myeloid leukemia with RARA gene
overexpression. For more information, visit www.syros.com and
follow us on Twitter (@SyrosPharma) and LinkedIn.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of
1995, including without limitation statements regarding Syros’
clinical development plans, the timing to report clinical data, the
ability to commercialize tamibarotene and deliver benefit to
patients, and the potential benefits of receiving Fast Track
designation. The words “anticipate,” “believe,” “continue,”
“could,” “estimate,” “expect,” “hope,” “intend,” “may,” “plan,”
“potential,” “predict,” “project,” “target,” “should,” “would,” and
similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words. Actual results or events could differ
materially from the plans, intentions and expectations disclosed in
these forward-looking statements as a result of various important
factors, including Syros’ ability to: advance the development of
its programs under the timelines it projects in current and future
clinical trials; demonstrate in any current and future clinical
trials the requisite safety, efficacy and combinability of its drug
candidates; sustain the response rates and durability of response
seen to date with its drug candidates; successfully develop a
companion diagnostic test to identify patients with the RARA
biomarker; obtain and maintain patent protection for its drug
candidates and the freedom to operate under third party
intellectual property; obtain and maintain necessary regulatory
approvals; identify, enter into and maintain collaboration
agreements with third parties; manage competition; manage expenses;
raise the substantial additional capital needed to achieve its
business objectives; attract and retain qualified personnel; and
successfully execute on its business strategies; risks described
under the caption “Risk Factors” in Syros’ Annual Report on Form
10-K for the year ended December 31, 2023, which is on file with
the Securities and Exchange Commission; and risks described in
other filings that Syros makes with the Securities and Exchange
Commission in the future.
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version on businesswire.com: https://www.businesswire.com/news/home/20240409254657/en/
Syros Karen Hunady Director of Corporate Communications
& Investor Relations 1-857-327-7321 khunady@syros.com
Investor Hannah Deresiewicz Stern Investor Relations,
Inc. 212-362-1200 hannah.deresiewicz@sternir.com
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