FDA Accepts New Drug Application and Grants Priority Review for Enasidenib in Relapsed or Refractory AML with an IDH2 Mutation
March 01 2017 - 7:30AM
Business Wire
PDUFA date set for Aug. 30, 2017
Celgene Corporation (NASDAQ:CELG) and Agios Pharmaceuticals
(NASDAQ:AGIO) today announced that the U.S. Food and Drug
Administration (FDA) has accepted Celgene’s New Drug Application
(NDA) for enasidenib (AG-221/CC-90007) for the treatment of
patients with relapsed or refractory acute myeloid leukemia (AML)
with an isocitrate dehydrogenase 2 (IDH2) mutation. The NDA was
granted Priority Review and has been given a Prescription Drug User
Fee Act (PDUFA) action date of Aug. 30, 2017. Celgene completed the
NDA submission in late December 2016.
“We accelerated this application – submitting the NDA just three
years after the first patient was treated in the enasidenib pivotal
investigational trial – because we believe that there is a
significant unmet need for people with relapsed or refractory AML,”
said Michael Pehl, president, Hematology/Oncology for Celgene. “The
acceptance of the enasidenib NDA is a significant milestone in what
we hope will be a new era of molecularly targeted therapies for
patients with this devastating disease.”
Enasidenib is a first-in-class, oral, targeted inhibitor of
mutant IDH2. The NDA submission is based on results from
AG221-C-001, a single-arm phase I/II study of enasidenib in
patients with advanced hematologic malignancies with an IDH2
mutation. Early data from the relapsed or refractory AML patients
in this study were presented at the 2015 American Society of
Hematology (ASH) Annual Meeting.
"Having received NDA acceptance and priority review for
enasidenib, we look forward to working with our partner Celgene and
the FDA to advance a first-in-class therapy for relapsed or
refractory AML with an IDH2 mutation,” said David Schenkein, M.D.,
chief executive officer at Agios. “We hope that the continued
adoption of molecular profiling and availability of new targeted
therapies such as enasidenib will have a significant impact on
patients living with AML.”
Additionally, Abbott has submitted a Premarket Approval (PMA)
application for the FDA approval of an IDH2 assay on the Abbott
m2000 RealTime System, a polymerase chain reaction (PCR) molecular
diagnostics instrument. IDH2 mutations occur in about 8 to 19
percent of AML patients. Recent publications have highlighted the
advances in the understanding of the genetics underlying AML and
the need for routine mutational analysis at diagnosis and
relapse.
Celgene is also evaluating enasidenib compared with conventional
therapy in older patients with an IDH2 mutation and relapsed or
refractory AML in the ongoing phase III IDHENTIFY trial
(NCT02577406).
Enasidenib is an investigational drug that has not been approved
for any use in any country.
About Acute Myelogenous Leukemia (AML)
AML, a cancer of blood and bone marrow characterized by rapid
disease progression, is the most common acute leukemia affecting
adults. Undifferentiated blast cells proliferate in the bone marrow
rather than mature into normal blood cells. AML incidence
significantly increases with age, and according to
the American Cancer Society, the median age of onset is 66.
Less than 10 percent of U.S. AML patients are eligible for bone
marrow transplant and the vast majority of patients do not respond
to chemotherapy and progress to relapsed/refractory AML. The
five-year survival rate for AML is approximately 20 to 25 percent.
IDH2 mutations are present in about 8 to 19 percent of AML
cases.
About Celgene
Celgene Corporation, headquartered in Summit, New
Jersey, is an integrated global biopharmaceutical company engaged
primarily in the discovery, development and commercialization of
innovative therapies for the treatment of cancer and inflammatory
diseases through next-generation solutions in protein homeostasis,
immuno-oncology, epigenetics, immunology and neuro-inflammation.
For more information, please visit www.celgene.com. Follow
Celgene on Social
Media: @Celgene, Pinterest, LinkedIn, Facebook and YouTube.
About Agios
Agios is focused on discovering and developing novel
investigational medicines to treat cancer and rare genetic diseases
through scientific leadership in the field of cellular metabolism.
In addition to an active research and discovery pipeline across
both therapeutic areas, Agios has multiple first-in-class
investigational medicines in clinical and/or preclinical
development. All Agios programs focus on genetically identified
patient populations, leveraging our knowledge of metabolism,
biology and genomics. For more information, please visit the
company's website at www.agios.com.
About Agios/Celgene Collaboration
Enasidenib is part of Celgene’s global strategic collaboration
with Agios focused on cancer metabolism. Under the terms of the
2010 collaboration agreement, Celgene has worldwide development and
commercialization rights for enasidenib. Agios continues to conduct
clinical development activities within the enasidenib development
program and is eligible to receive reimbursement for those
development activities and up to $120 million in payments assuming
achievement of certain milestones and royalties on net sales.
Celgene and Agios intend to co-commercialize enasidenib in the U.S.
Celgene will reimburse Agios for costs incurred for its
co-commercialization efforts.
Forward-Looking Statements
This press release contains forward-looking statements, which
are generally statements that are not historical facts.
Forward-looking statements can be identified by the words
"expects," "anticipates," "believes," "intends," "estimates,"
"plans," "will," “outlook” and similar expressions. Forward-looking
statements are based on management’s current plans, estimates,
assumptions and projections, and speak only as of the date they are
made. Neither Celgene nor Agios undertake any obligation to update
any forward-looking statement in light of new information or future
events, except as otherwise required by law. Forward-looking
statements involve inherent risks and uncertainties, most of which
are difficult to predict and are generally beyond each company’s
control. Actual results or outcomes may differ materially from
those implied by the forward-looking statements as a result of the
impact of a number of factors, many of which are discussed in more
detail in the Annual Report on Form 10-K and other reports of each
company filed with the Securities and Exchange Commission.
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For
Celgene:Investors:908-673-9628investors@celgene.comorMedia:908-673-2275media@celgene.comorFor
Agios:Investors:Kendra Adams, 617-844-6407Senior Director,
Investor & Public RelationsKendra.Adams@agios.comorRenee Leck,
617-649-8299Senior Manager, Investor & Public
RelationsRenee.Leck@agios.comorMedia:Holly Manning,
617-844-6630Associate Director, Corporate
CommunicationsHolly.Manning@agios.com
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