DE-INCYTE
29.1.2021 19:38:08 CET | Business Wire | Press release
Incyte (Nasdaq:INCY) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the conditional marketing authorization of pemigatinib for the treatment of adults with unresectable 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 positive CHMP opinion is a crucial milestone for patients with cholangiocarcinoma, who often have very limited treatment options due to the difficulty of identifying patients during the early disease stages,” said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapeutics, Incyte. “Following the recent FDA approval of pemigatinib (Pemazyre® ), we are delighted to be closer to offering the first targeted therapy in Europe to benefit these patients.”
The CHMP opinion is based on data from the FIGHT-202 study evaluating the safety and efficacy of pemigatinib in adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGF/FGFR status. The CHMP’s opinion to recommend the use of pemigatinib is now being reviewed by the European Commission, which has the authority to grant marketing authorizations for medicinal products in the European Union (EU). If approved, pemigatinib will be the first targeted treatment in the EU indicated for patients with unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement and would be commercialized under the brand name Pemazyre.
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 poor1,2 . In Europe, the incidence of cholangiocarcinoma ranges between 6,000 – 8,0003,4 . FGFR2 fusions or rearrangements occur almost exclusively in iCCA, where they are observed in 10-16 percent of patients5,6,7 .
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; 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 (FI
broblast G
rowth factor receptor in oncology and H
ematology T
rials) 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-302 is a 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 for the treatment of, and whether or when pemigatinib might provide a successful treatment option for, patients with unresectable locally advanced or metastatic cholangiocarcinoma, 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 European regulatory authorities or other regulatory authorities, including the U.S. FDA; 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, 2020. The Company disclaims any intent or obligation to update these forward-looking statements.
__________________
1
Banales JM, et al. Nat Rev Gastroenterol Hepatol. 2016;13:261‒280.
2
Uhlig J, et al. Ann Surg Oncol. 2019;26:1993–2000.
3
Kirstein MM, Vogel A. Visc Med 2016; 32: 395-400.
4
Countries factored include: UK, Germany, France, Spain, Italy, Switzerland, Denmark, Finland, Poland and Austria
5
Graham RP, et al. Hum Pathol. 2014;45:1630‒1638.
6
Ang C. J. Gastroenterol Hepatol. 2015;30:1116‒1122.
7
Ross JS et al. The Oncologist. 2014;19:235–242.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210129005533/en/
Link:
About Business Wire
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
AM Intelligence Expands NVIDIA Vera Rubin AI Factory Buildout in India and Malaysia5.10.2026 20:16:00 CEST | Press release
Two further binding orders of ~20,000 NVIDIA GPUs take AMI's committed NVIDIA Vera Rubin capacity to approximately ~29,000 GPUs and close to 100 MW, part of its global development pipeline of ~400 MW AM Intelligence (“AMI”), the AI infrastructure platform set up by Promoters of Greenko, today announced two further firm and binding orders for 20,000 NVIDIA Rubin GPUs, to be deployed as NVIDIA Vera Rubin NVL72 rack-scale systems. Building on its first AI factory in Hyderabad, the expansion is designed to give cloud providers, enterprises and AI developers access to large-scale computing capacity closer to where they build and deploy AI. These orders are in addition to the AMI's inaugural commitment announced on August 25, 2026, for 9,000 NVIDIA Rubin GPUs at its first AI Factory in Hyderabad. This follow-on capacity totalling ~70 megawatts (MW) will be deployed at Malaysia and India with delivery scheduled for Q2 2027. Taken together, the three orders bring AMI's committed frontier compu
SES Announces Final Results of Its Cash Tender Offer5.10.2026 19:49:00 CEST | Press release
THIS ANNOUNCEMENT RELATES TO THE DISCLOSURE OF INFORMATION THAT QUALIFIED OR MAY HAVE QUALIFIED AS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE 7(1) OF THE MARKET ABUSE REGULATION (EU) 596/2014. NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN OR INTO OR TO ANY PERSON LOCATED OR RESIDENT IN, OR AT ANY ADDRESS IN, THE UNITED STATES OF AMERICA, ITS TERRITORIES AND POSSESSIONS (INCLUDING PUERTO RICO, THE U.S. VIRGIN ISLANDS, GUAM, AMERICAN SAMOA, WAKE ISLAND AND THE NORTHERN MARIANA ISLANDS), ANY STATE OF THE UNITED STATES OF AMERICA OR THE DISTRICT OF COLUMBIA (THE UNITED STATES) OR TO ANY U.S. PERSON (AS DEFINED IN REGULATION S OF THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED (THE SECURITIES ACT)) OR IN OR INTO ANY JURISDICTION WHERE IT IS UNLAWFUL TO RELEASE, PUBLISH OR DISTRIBUTE THIS ANNOUNCEMENT. SES (the “Offeror”) announces today the final results and pricing of its invitation to holders of its outstanding €500,000,000 0.875 per cent. Guaranteed Notes due 4 November 2027
Cessna Skyhawk Veris Virtual Reality Flight Training Device to Make Show Debut at NBAA-BACE in Las Vegas5.10.2026 17:00:00 CEST | Press release
Attendees can experience how the dual-seat Cessna Skyhawk Veris brings instructors and students together for realistic, immersive flight training TRU Simulation + Training Inc., a Textron Inc. (NYSE:TXT) company, and an affiliate of Textron Aviation, announced today its Veris Virtual Reality Flight Training Device (FTD) configured for the Cessna Skyhawk is making its show debut at the 2026 National Business Aviation Association Business Aviation Convention & Exhibition (NBAA-BACE). The show debut builds on momentum from NBAA-BACE 2025, where TRU Simulation announced a purchase agreement with US Aviation Academy for five Cessna Skyhawk Veris devices, with options for additional units. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261005927782/en/ Cessna Skyhawk Veris Virtual Reality Flight Training Device to make show debut at NBAA-BACE in Las Vegas This year, NBAA-BACE attendees will have the opportunity to experience the C
FuzeBox AI Named Founding Co-Author of SPUR Coalition Technical Committee on Verifying AI Content Use5.10.2026 15:00:00 CEST | Press release
A new technical committee will define how publishers can independently confirm AI companies' reports of content use. FuzeBox AI has been named by the SPUR Coalition, an international nonprofit of 37 news and media organizations, as one of four founding co-authors of its Evidence Profile Technical Committee, adopted Sept. 2, 2026, to draft an evidence profile for SPUR's Content Telemetry standard: a way for publishers to verify AI usage reports without depending on the reporting company's cooperation. Under SPUR's current standard, AI companies self-report their content use. A company that skips reporting leaves no record, and publishers can't check what they do receive. On July 10, 2026, FuzeBox proposed its Verified Provenance Telemetry Standard (VPTS): publishers seed content with detectable markers, then verify their appearance in AI outputs via an auditable ledger, with no change to SPUR's standard. Within 48 hours, three organizations filed related proposals: ProRata on usage magn
Mary Kay Introduces the K-Beauty Texture Edit5.10.2026 14:02:00 CEST | Press release
Special-Edition Korea-Made Skin Care Collection Launches In 40 Markets, Available While Supplies Last Mary Kay Inc.,the iconic beauty giant announced today the launch of the K-Beauty Texture Edit, aspecial-edition skin care collection available while supplies last. The collection builds on the momentum of the company's largest consumer-facing global brand platform, Beauty Is More Beautiful Shared™ which launched in September. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261005600130/en/ Mary Kay's Special Edition K-Beauty Texture Edit is a trend-forward collection which includes three Korea-made products: the Mary Kay® Melt-In Cleansing Balm, Mary Kay® Snail Gel Face Patches and Mary Kay® Collagen Moisturizing Gel. (Image Credit: Mary Kay Inc.) Inspired by Korea's globally influential skin care and self-care philosophy designed to bring playful textures, innovative ingredients, and elevated beauty experiences, the K-Beauty
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