Incyte Announces the Validation by the European Medicines Agency of its Marketing Authorization Application for Pemigatinib in Patients with Cholangiocarcinoma
7.1.2020 14:00:00 EET | Business Wire | Press release
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):13-26
5
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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200107005093/en/
Contact information
Media
Catalina Loveman +1 302 498 6171
cloveman@incyte.com
Ela Zawislak + 41 21 343 3113
ezawislak@incyte.com
Investors
Michael Booth, DPhil +1 302 498 5914
mbooth@incyte.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Komainu Completes Two-Way Digital Asset Transfers for First Abu Dhabi Bank as Institutional Custody Framework Goes Live3.11.2026 11:30:00 EET | Press release
Komainu, a regulated digital asset services provider and custodian backed by Laser Digital and Blockstream, has completed the two-way transfer of a portfolio of digital assets with First Abu Dhabi Bank (FAB) through the institutional digital asset custody framework the two firms have established. The transfers settled instantly. The milestone marks the operationalisation of Komainu’s collaboration with FAB Global Markets, integrating regulated digital asset custody and connectivity capabilities with FAB’s existing infrastructure. The transfers demonstrate the bank’s ability to move digital assets both into and out of the custody environment, validating the infrastructure required to support institutional digital asset activity. The framework has also been designed to support future institutional financing solutions, including lending backed by digital assets held in regulated custody. This provides a foundation for FAB to further integrate digital assets into its financial markets infr
Klarna Expands Partnership With Mollie, Bringing Enhanced Dispute Management and Consumer FX to Merchants Across Europe3.11.2026 11:00:00 EET | Press release
Klarna, the everyday finance network, announced today an expanded agreement with Mollie, one of Europe’s leading payment service providers. Building on their existing partnership, the new contract brings additional Klarna capabilities, including enhanced dispute management and consumer FX, to Mollie’s more than 350,000 merchants. The new features will roll out across all Mollie’s integrations, via direct API, hosted payment page and via their extensive Platform partner plug in ecosystem. Merchants already offering Klarna through Mollie will gain access to these features through their existing integration. Merchants new to Klarna can offer Pay in Full, Pay in 3 interest-free installments and Financing at checkout, and can enable it within minutes. With Mollie’s recent acquisition of GoCardless and coverage across all EEA markets, the expanded agreement extends Klarna’s reach and product offering across the region. “This deepened agreement with Mollie opens up Klarna to merchants across
Bizzmine Unveils More Than 40 Quality, EHS and Compliance Solutions Alongside Major Advances in AI and User Experience3.11.2026 10:47:00 EET | Press release
Bizzmine has announced a major expansion of its intelligent QHSE platform at Digital Summit 2026. The company presented more than 40 ready to use solutions spanning Quality, Environment, Health and Safety (EHS) and Compliance, together with advances in artificial intelligence and a fundamentally renewed user experience. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261102147396/en/ Bizzmine summit panel discussion The latest developments give organisations a broader range of operational processes to manage in one environment, with connected information, common governance and a clear view of responsibilities and completed work across locations. “What impresses me most is how quickly we can now turn innovation into value for our customers,” said Mark Abbas, CEO of Bizzmine. “In just one year, we have expanded from around 15 solutions to more than 40, got recognized by leading industry analysts for our EHS capabilities, introd
Hightouch Launches Match Booster in Europe, Raising Match Rates Without Compromising Compliance3.11.2026 10:02:00 EET | Press release
Hightouch, the leading agentic marketing platform, today launched Match Booster in the UK, Germany, France, Spain, and Italy. Match Booster helps brands, agencies, media networks, and publishers reach more of their customers on more than 50 ad platforms, including Google, Meta, Amazon, TikTok, and The Trade Desk, by adding to their consented first-party data instead of replacing it. Until now, European advertisers have had two options. They could send first-party data to ad platforms alone and accept the match rates they got. Or they could hand it to a traditional onboarding provider that swaps it for a proprietary ID and drops any customer its graph can’t find, sometimes leaving audiences smaller than they started. Global companies also end up running separate US and EU workflows to meet data residency rules. “Better match rates shouldn’t depend on where your customers live,” said Matthew Lubeck, General Manager, EMEA at Hightouch. “European companies have been told that more reach me
Building on Netherlands NextGen Momentum, Trilliant Showcases Why the Next Generation of AMI is Being Defined by Choice at Enlit Europe 20263.11.2026 10:00:00 EET | Press release
Trilliant, a technology platform partner enabling utilities to gain real-time visibility and optimize performance across an increasingly dynamic energy landscape, will showcase its Power of Choice approach at Enlit Europe 2026, taking place 10–12 November in Vienna, Austria. The company will highlight how intelligent software and device-independent technologies help utilities modernize infrastructure and prepare for evolving grid demands. Trilliant’s participation at Enlit Europe follows its recent selection by Dutch distribution system operators to support the Netherlands’ NextGen smart metering programme. Trilliant’s role includes developing and delivering gateways supported by its transformed UnitySuite® platform, which will be demonstrated during the conference. At Enlit Europe, Trilliant will spotlight its Power of Choice approach, enabling utilities to integrate multiple vendors and technologies without proprietary lock-in while building a foundation for next-generation AMI and g
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom