Incyte Announces the Validation by the European Medicines Agency of its Marketing Authorization Application for Pemigatinib i...
January 07 2020 - 6:00AM
Business Wire
Incyte (Nasdaq:INCY) today announced the validation of the
Company’s Marketing Authorization Application (MAA) for pemigatinib
for the treatment of adults with locally advanced or metastatic
cholangiocarcinoma with a fibroblast growth factor receptor 2
(FGFR2) fusion or rearrangement that is relapsed or refractory
after at least one line of systemic therapy. The European Medicines
Agency’s (EMA) validation of the MAA confirms that the submission
is sufficiently complete to begin the formal review process.
“The EMA’s validation of Incyte’s Marketing Authorization
Application opens the review process as we seek to bring the first
targeted therapy to Europe for patients with cholangiocarcinoma,”
said Peter Langmuir, M.D., Group Vice President, Targeted
Therapeutics, Incyte. “The need for new therapies for
cholangiocarcinoma was also recently recognized by the U.S. Food
and Drug Administration’s acceptance, for Priority Review, of our
New Drug Application for pemigatinib this past November. We are
looking forward to continuing to work with regulatory authorities
to bring this novel targeted therapy to eligible patients around
the world.”
The MAA application is based on data from the FIGHT-202 study
evaluating pemigatinib as a treatment for patients with previously
treated, locally advanced or metastatic cholangiocarcinoma.1
Cholangiocarcinoma is a rare cancer that forms in the bile duct.
It is classified based on its origin: intrahepatic
cholangiocarcinoma (iCCA) occurs in the bile duct inside the liver
and extrahepatic cholangiocarcinoma occurs in the bile duct outside
the liver. Patients with cholangiocarcinoma are often diagnosed at
a late or advanced stage when the prognosis is poor.2,3 The
incidence of cholangiocarcinoma varies regionally, but ranges
between 0.4 – 1.8 per 100,000 in Europe.4 FGFR2 fusions or
rearrangements occur almost exclusively in iCCA, where they are
observed in 10-16 percent of patients.5-7
About FIGHT-202
The FIGHT-202 Phase 2, open-label, multicenter study
(NCT02924376) is evaluating the safety and efficacy of pemigatinib
– a selective fibroblast growth factor receptor (FGFR) inhibitor –
in adult (age ≥ 18 years) patients with previously treated, locally
advanced or metastatic cholangiocarcinoma with documented FGF/FGFR
status.
Patients were enrolled into one of three cohorts – Cohort A
(FGFR2 fusions or rearrangements), Cohort B (other FGF/FGFR genetic
alterations) or Cohort C (no FGF/FGFR genetic alterations). All
patients received 13.5 mg pemigatinib orally once daily (QD) on a
21-day cycle (two weeks on/one week off) until radiological disease
progression or unacceptable toxicity.
The primary endpoint of FIGHT-202 is overall response rate (ORR)
in Cohort A, assessed by independent review per RECIST v1.1.
Secondary endpoints include ORR in Cohorts B, A plus B, and C;
progression free survival (PFS), overall survival (OS), duration of
response (DOR), disease control rate (DCR) and safety in all
cohorts.
For more information about FIGHT-202, visit
https://clinicaltrials.gov/ct2/show/NCT02924376.
About FIGHT
The FIGHT (FIbroblast Growth factor receptor
in oncology and Hematology Trials) clinical
trial program includes ongoing Phase 2 and 3 studies investigating
safety and efficacy of pemigatinib therapy across several
FGFR-driven malignancies. Phase 2 monotherapy studies include
FIGHT-202, as well as FIGHT-201 investigating pemigatinib in
patients with metastatic or surgically unresectable bladder cancer,
including with activating FGFR3 mutations or
fusions/rearrangements; FIGHT-203 in patients with
myeloproliferative neoplasms with activating FGFR1
fusions/rearrangements; FIGHT-207 in patients with previously
treated, locally-advanced/metastatic or surgically unresectable
solid tumor malignancies harboring activating FGFR mutations or
fusions/rearrangements, irrespective of tumor type. FIGHT-205 is a
Phase 2 study investigating pemigatinib plus pembrolizumab
combination therapy and pemigatinib monotherapy in patients with
previously untreated, metastatic or unresectable bladder cancer
harboring FGFR3 mutations or fusions/rearrangements who are not
eligible to receive cisplatin. FIGHT-302 is a recently initiated
Phase 3 study investigating pemigatinib as a first-line treatment
for patients with cholangiocarcinoma with FGFR2 fusions or
rearrangements.
About FGFR and Pemigatinib
Fibroblast growth factor receptors (FGFRs) play an important
role in tumor cell proliferation and survival, migration and
angiogenesis (the formation of new blood vessels). Activating
fusions, rearrangements, translocations and gene amplifications in
FGFRs are closely correlated with the development of various
cancers.
Pemigatinib is a potent, selective, oral inhibitor of FGFR
isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated
selective pharmacologic activity against cancer cells with FGFR
alterations.
About Incyte
Incyte is a Wilmington, Delaware-based, global biopharmaceutical
company focused on finding solutions for serious unmet medical
needs through the discovery, development and commercialization of
proprietary therapeutics. For additional information on Incyte,
please visit Incyte.com and follow @Incyte.
Forward Looking Statements
Except for the historical information set forth herein, the
matters set forth in this press release, including statements
regarding whether or when pemigatinib might be approved in the EU,
the US or elsewhere for the treatment of, and whether or when
pemigatinib might provide a treatment option for, patients with
previously treated, locally advanced or metastatic
cholangiocarcinoma with FGFR2 fusions or rearrangements, and the
FIGHT clinical trial program. These forward-looking statements are
based on the Company’s current expectations and subject to risks
and uncertainties that may cause actual results to differ
materially, including unanticipated developments in and risks
related to: unanticipated delays; further research and development
and the results of clinical trials possibly being unsuccessful or
insufficient to meet applicable regulatory standards or warrant
continued development; the ability to enroll sufficient numbers of
subjects in clinical trials; determinations made by the EMA; the
Company’s dependence on its relationships with its collaboration
partners; the efficacy or safety of the Company’s products and the
products of the Company’s collaboration partners; the acceptance of
the Company’s products and the products of the Company’s
collaboration partners in the marketplace; market competition;
sales, marketing, manufacturing and distribution requirements;
greater than expected expenses; expenses relating to litigation or
strategic activities; and other risks detailed from time to time in
the Company’s reports filed with the Securities and Exchange
Commission, including its Form 10-Q for the quarter ending
September 30, 2019. The Company disclaims any intent or obligation
to update these forward-looking statements.
____________________1 Vogel A, et al. FIGHT-202: A Phase 2 Study
of Pemigatinib in Patients with Previously Treated Locally Advanced
or Metastatic Cholangiocarcinoma. Proffered paper #2550. European
Society for Medical Oncology. 2019.2 Banales JM, et al. Nat Rev
Gastroenterol Hepatol. 2016;13:261‒280.3 Uhlig J, et al. Ann Surg
Oncol. 2019;26:1993–2000.4 Blechacz B, et al. Gut and Liver. 2017;
11(1):13-265 Graham RP, et al. Hum Pathol. 2014;45:1630‒1638.6
Farshidfar F, et al. Cell Rep. 2017;18(11):2780–2794.7 Ross JS et
al. The Oncologist. 2014;19:235–242.
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MediaCatalina Loveman +1 302 498
6171cloveman@incyte.com
Ela Zawislak + 41 21 343 3113ezawislak@incyte.com
InvestorsMichael Booth, DPhil +1 302 498
5914mbooth@incyte.com
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