- Fast Track designation granted by U.S. FDA for evaluation of
darovasertib in combination with crizotinib in adult patients being
treated for metastatic uveal melanoma (MUM)
- Enables darovasertib / crizotinib development program to access
expedited regulatory review processes, including potential
eligibility for accelerated approval / priority review
SOUTH
SAN FRANCISCO, Calif., Dec. 5, 2022
/PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a
synthetic lethality focused precision medicine oncology company
committed to the discovery and development of targeted
therapeutics, announced that the U.S. Food and Drug
Administration (FDA) has granted Fast Track designation to
IDEAYA's development program investigating darovasertib, a
potential first-in-class protein kinase C (PKC) inhibitor, for use
in combination with crizotinib, an investigational cMET inhibitor,
for the treatment of adult patients with metastatic uveal
melanoma.
"We are extremely pleased to receive the U.S. FDA Fast Track
designation as we prepare to initiate a potential Phase 2/3
registrational trial to evaluate the darovasertib and crizotinib
combination in patients with MUM. The Fast Track designation
acknowledges MUM as a serious condition and the potential for the
darovasertib / crizotinib combination to treat this unmet medical
need," said Dr. Darrin Beaupre,
Senior Vice President and Chief Medical Officer at IDEAYA
Biosciences.
Fast Track is a U.S. FDA process designed to facilitate the
development and expedite the review of drugs to treat serious
conditions and fill an unmet medical need. Under the Fast Track
designation, the darovasertib / crizotinib development program in
MUM is eligible for various expedited regulatory review processes,
including generally more frequent FDA interactions (e.g., meetings,
written communications), potential eligibility for rolling review
of a New Drug Application (NDA) and potential accelerated approval
and priority review of an NDA.
Darovasertib was previously also designated as an Orphan Drug by
the U.S. FDA in Uveal Melanoma (UM), including in MUM, entitling
IDEAYA to certain potential tax credits, exemptions from user fees,
and statutory marketing exclusivity.
IDEAYA is targeting initiation of a potential
registration-enabling trial for the darovasertib and crizotinib
combination in MUM in Q1 2023, subject to FDA feedback and
guidance.
IDEAYA is also planning to initiate a company-sponsored Phase 1
clinical trial in Q4 2022 to evaluate darovasertib monotherapy in
neoadjuvant UM patients. The preliminary development approach
contemplates clinical endpoints such as organ preservation and/or
vision preservation proximal to primary interventional treatments.
Additional information on the company's plans to evaluate
darovasertib, including scientific insights and clinical
development opportunities in the neoadjuvant setting, will be
highlighted in an Investor R&D Day webcast being hosted by
IDEAYA on December 12, 2022, at
8:00 am - 9:30 am ET. Registration is
available at https://ir.ideayabio.com/events or
https://lifescievents.com/event/ideaya-rd-day/.
About IDEAYA Biosciences
IDEAYA is a synthetic lethality-focused precision medicine
oncology company committed to the discovery and development of
targeted therapeutics for patient populations selected using
molecular diagnostics. IDEAYA's approach integrates capabilities in
identifying and validating translational biomarkers with drug
discovery to select patient populations most likely to benefit from
its targeted therapies. IDEAYA is applying its early research and
drug discovery capabilities to synthetic lethality – which
represents an emerging class of precision medicine
targets.
Forward-Looking
Statements
This press release contains forward-looking statements,
including, but not limited to, statements related to (i) the timing
of initiating a potential registration-enabling trial for the
darovasertib and crizotinib combination in MUM, (ii) the
timing of initiating a company-sponsored Phase 1 clinical trial to
evaluate darovasertib monotherapy in neoadjuvant UM patients, and
(iii) the timing and content of IDEAYA's Investor R&D Day
webcast. IDEAYA undertakes no obligation to update or revise any
forward-looking statements. For a further description of the risks
and uncertainties that could cause actual results to differ from
those expressed in these forward-looking statements, as well as
risks relating to the business of IDEAYA in general, see IDEAYA's
Quarterly Report on Form 10-Q filed on November 8, 2022, and any current and periodic
reports filed with the U.S. Securities and Exchange Commission.
Investor and Media Contact
IDEAYA Biosciences
Paul Stone
Senior Vice President and Chief Financial Officer
investor@ideayabio.com
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SOURCE IDEAYA Biosciences, Inc.