Incyte Announces Positive CHMP Opinion for Pemigatinib for the Treatment of Adults With Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma With a Fibroblast Growth Factor Receptor 2 (FGFR2) Fusion or Rearrangement
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.
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.
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-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.
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.
Executive Director, Public Affairs
+1 302 498 6171
Director, Public Affairs
+41 21 343 3113
Dr. Michael Booth
Division VP, IR & Global Responsibility
+1 302 498 5914
Senior Director, Investor Relations
+1 302 274 4773
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
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
The Estée Lauder Companies to Issue $600 Million of Senior Notes2.3.2021 01:28:00 CET | Press release
The Estée Lauder Companies Inc. (NYSE: EL) today announced the offering and pricing of $600 million aggregate principal amount of 1.950% Senior Notes due 2031. The offering was made pursuant to an effective registration statement filed by The Estée Lauder Companies Inc. with the Securities and Exchange Commission and effective as of May 21, 2018. The closing of the offering is expected to occur on or about March 4, 2021. The Company intends to use the net proceeds of the offering for general corporate purposes, which may include funding a portion of the purchase price to increase its investment in DECIEM Beauty Group Inc., operating expenses, working capital, capital expenditures and redemption and repayment of short-term or long-term borrowings, including refinancing the 1.700% Senior Notes due May 10, 2021. Pending any specific application, the Company may initially invest funds in short-term marketable securities. BofA Securities, Inc., BNP Paribas Securities Corp., Goldman Sachs &
Lattice Expands mVision Solutions Stack Capabilities1.3.2021 22:00:00 CET | Press release
Lattice Semiconductor Corporation (NASDAQ: LSCC), the low power programmable leader, launched the latest version of its award-winning solutions stack for low power embedded vision systems, Lattice mVision™ 2.0. The new version features multiple updates that further accelerate the design of embedded vision applications for industrial, automotive, medical, and smart consumer systems. It includes support for popular new image sensors used in industrial and automotive systems and a new image signal processing IP core and reference design to help developers design smart vision applications at the Edge. The stack also includes support for the Lattice Propel™ design environment to simplify development of vision systems with an embedded RISC-V processor. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210301005142/en/ The Lattice mVision solutions stack is a comprehensive collection of modular hardware platforms, IP building blocks,
Lattice Sentry Solutions Stack 2.0 Enhances Cyber Resiliency with New Expanded Capabilities1.3.2021 22:00:00 CET | Press release
As the next step in its ongoing mission to deliver secure, cyber-resilient system control solutions, Lattice Semiconductor Corporation (NASDAQ: LSCC), the low power programmable leader, today announced the latest version of its solutions stack for secure system control, Lattice Sentry™ 2.0. The solutions stack enables next-generation hardware Root-of-Trust (HRoT) solutions compliant with NIST Platform Firmware Resiliency (PFR) Guidelines (NIST SP-800-193) and supporting 384-bit encryption. This new version of Lattice Sentry addresses the rapidly evolving security requirements of current and emerging server platforms by providing developers an efficient and secure way to quickly implement enhanced system and cryptographic applications. The stack supports firmware security for the communications, computing, industrial, automotive, and smart consumer markets. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210301005143/en/ The L
Verimatrix’s Lu Bolden To Speak on Latest Video Piracy Trends During SportsPro OTT Summit USA1.3.2021 17:45:00 CET | Press release
Regulatory News: Verimatrix, (Paris:VMX) (Euronext Paris: VMX), the leader in powering the modern connected world with people-centered security, today announced that Lu Bolden, Chief Revenue Officer, is scheduled to participate in a virtual panel discussion during this year’s SportsPro OTT Summit USA from 10:30 to 11:45 a.m. PST on Thursday, March 4. Titled, “Taking on Piracy in 2021,” the panel is moderated by Chris Kuelling, Executive Director of the International Broadcaster Coalition Against Piracy, and includes the following other speakers: Michele Gosetti, Head of Global Sales & Marketing, Eurovision Daniel Ghosh-Roy, Chief Digital Officer, Professional Fighters League The value of sports content remains strong, with broadcast revenue growing in emerging sectors such as niche sporting events and e-sports. But the industry is undergoing massive changes driven by new technologies and business models -- with some sectors under duress. Securing live sports revenue is critical to the
Deque Systems Launches axe DevTools Pro1.3.2021 17:00:00 CET | Press release
Deque Systems, the trusted leader in digital accessibility, announced today the availability of axe™ DevTools Pro. Built upon the wildly popular free axe browser extension, axe DevTools Pro is a huge step forward for digital equality, enabling dev teams to address accessibility at the source, using groundbreaking human and machine learning technology. Developers and novices alike can use axe DevTools Pro to run automated and Intelligent Guided Tests™ on their websites and applications, which directly address the core blockages preventing people with disabilities from enjoying all the web has to offer. Axe DevTools Pro can identify 76 to 84 percent of accessibility issues on a webpage, the industry’s broadest range of options for detecting and remediating accessibility problems. Over 19,000 developers and other users provided input to refine axe DevTools Pro during the 16-month beta period. Many of these suggestions have already been implemented. Axe DevTools Pro is available now at www
CMG Chief: 'Ancient Chinese Literature' TV Show Reveals Nation's Soul1.3.2021 16:05:00 CET | Press release
The new hit television show "Ancient Chinese Literature" has promoted traditional Chinese culture and did well in telling Chinese stories to the world, said Shen Haixiong, the president of China Media Group (CMG) on Monday. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210301005624/en/ The CMG production interprets ancient Chinese books and brings classics to life with short stage plays. The show premiered on February 12, the first day of the Chinese New Year, and has set record ratings in its category, becoming a hot topic on Chinese social media. "It's not out of our expectation," wrote Shen in an article titled "Why we created the program 'Ancient Chinese Literature'," which was published in the fifth issue of Qiushi, the flagship magazine of the Communist Party of China (CPC) Central Committee. Shen said that the profound Chinese culture has carried forward for 5,000 years and is still full of vitality, noting that the
Auth0 Names Jameeka Green Aaron as Chief Information Security Officer1.3.2021 15:00:00 CET | Press release
Auth0, the identity platform for application teams, today announced that Jameeka Green Aaron has joined the company as Chief Information Security Officer (CISO). Aaron brings more than 20 years of industry experience and will be responsible for the holistic security and compliance of Auth0’s platform, products, and corporate environment. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210301005173/en/ Jameeka Green Aaron joins Auth0 as CISO (Photo: Business Wire) Aaron is a recognized industry thought leader and has dedicated two decades to managing and improving information security systems at each of her previous positions, including Nike, Hurley, Lockheed Martin, and the U.S. Navy. She is also committed to advancing women and people of color in Science, Technology, Engineering, and Mathematics (STEM) fields and has participated in the U.S. State Department’s TechWomen program and the National Urban League of Young Professi