Incyte Announces the European Commission Approval of Pemazyre ® (pemigatinib) as a Treatment for Adults with Locally Advanced or Metastatic Cholangiocarcinoma with a Fibroblast Growth Factor Receptor 2 (FGFR2) Fusion or Rearrangement
Incyte (Nasdaq:INCY) today announced that the European Commission (EC) has approved Pemazyre® (pemigatinib) for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy. The decision follows the positive opinion received from the European Medicines Agency’s Committee for Medicinal Products for Human Use in January 2021 recommending the conditional marketing authorization of Pemazyre.
“Pemazyre’s approval is a crucial milestone for patients with FGFR2 positive cholangiocarcinoma. It is the first new treatment option to be made available to these patients in the EU in over a decade and has demonstrated a high rate of durable responses in a setting where historically there has been no effective standard of care,” said Hervé Hoppenot, Chief Executive Officer, Incyte. “We now look forward to working with individual countries in Europe to ensure eligible patients can access this new treatment as soon as possible.”
The EC decision is based on data from the FIGHT-202 study evaluating the safety and efficacy of Pemazyre in adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGF/FGFR status. Interim results from FIGHT-202 demonstrated that in patients harboring FGFR2 fusions or rearrangements (Cohort A [108 patients]), Pemazyre monotherapy resulted in an overall response rate (ORR) of 37 percent (primary endpoint) and a median duration of response (DOR) of 8 months (secondary endpoint) based on an independent central radiographic review. Pemazyre was generally well tolerated. Warnings and precautions for Pemazyre include high and low levels of phosphate in the blood, vision or eye problems, blood creatinine increase and for women who are pregnant, a risk of harm to the fetus.
“The data from the FIGHT-202 study has demonstrated the potential benefits that pemigatinib may have for eligible patients living with cholangiocarcinoma,” said Eric Van Cutsem, M.D., Ph.D., Professor and Division Head of Digestive Oncology, University of Leuven (KUL) and University Hospitals Gasthuisberg, Leuven, Belgium. “Pemazyre offers a much-needed option to eligible patients that have only had few effective treatment options until today.”
Cholangiocarcinoma is a rare cancer that forms in the bile duct. It is classified based on its origin: intrahepatic cholangiocarcinoma 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 intrahepatic cholangiocarcinoma, where they are observed in 10-16 percent of patients5,6,7.
“Historically, patients living with advanced cholangiocarcinoma have had very limited treatment options,” said Helen Morement, CEO, AMMF – The Cholangiocarcinoma Charity. “We are encouraged to see new, targeted therapies starting to be approved in Europe, giving hope to those in desperate need of alternatives."
The FIGHT-202 Phase 2, open-label, multicenter study (NCT02924376) is evaluating the safety and efficacy of Pemazyre – 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 13.5mg Pemazyre 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 Pemazyre therapy across several FGFR-driven malignancies. Phase 2 monotherapy studies include FIGHT-202, as well as FIGHT-201 investigating Pemazyre 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 Pemazyre as a first-line treatment for patients with cholangiocarcinoma with FGFR2 fusions or rearrangements.
About Pemazyre® (pemigatinib)
Pemazyre is a kinase inhibitor indicated in the United States for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test8. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
In Japan, Pemazyre is approved for the treatment of patients with unresectable biliary tract cancer (BTC) with a fibroblast growth factor receptor 2 (FGFR2) fusion gene, worsening after cancer chemotherapy.
In Europe, Pemazyre is approved for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.
Pemazyre 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.
Pemazyre is marketed by Incyte in the United States, Europe and Japan. Incyte has granted Innovent Biologics, Inc. rights to develop and commercialize pemigatinib in hematology and oncology in Mainland China, Hong Kong, Macau and Taiwan. Incyte has retained all other rights to develop and commercialize pemigatinib outside of the United States.
Pemazyre is a trademark of Incyte Corporation.
Safety Information from the EU Summary of Product Characteristics (SmPC)
Pemazyre may cause serious adverse reactions. The most common serious adverse reactions were hyponatremia and blood creatinine increase.
The most common adverse reactions were hyperphosphatemia, alopecia, diarrhoea, nail toxicity, fatigue, nausea, dysgeusia, stomatitis, constipation, dry mouth, dry eye, arthralgia, hypophosphatemia, dry skin and palmar-plantar erythrodysaesthesia syndrome.
Prolonged hyperphosphatemia can cause precipitation of calcium-phosphate crystals that can lead to hypocalcemia, soft tissue mineralization, anemia, secondary hyperparathyroidism, muscle cramps, seizure activity, QT interval prolongation and arrhythmias. Soft tissue mineralization, including cutaneous calcification and calcinosis, have been observed with Pemazyre treatment. Recommendations for management of hyperphosphatemia include dietary phosphate restriction, administration of phosphate-lowering therapy and dose modification when required.
Pemazyre can cause serous retinal detachment reactions, which may present with symptoms such as blurred vision, visual floaters or photopsia. Ophthalmological examination, including optical coherence tomography (OCT) should be performed prior to initiation of therapy and every 2 months for the first 6 months of treatment, every 3 months afterwards, and urgently at any time for visual symptoms. For serous retinal detachment reactions, the dose modification guidelines should be followed.
Pemazyre should not be used during pregnancy unless the clinical condition of the women requires treatment with Pemazyre. Patients with cancer cells that have spread into the brain or spinal cord should notify their physician before initiating treatment with Pemazyre.
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 Pemazyre might provide a successful treatment option for patients with locally advanced or metastatic cholangiocarcinoma, and the FIGHT clinical trial program, contain predictions, estimates, and other forward-looking statements.
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 and the ability to enroll subjects in accordance with planned schedules; the effects of the COVID-19 pandemic and measures to address the pandemic on the Company’s clinical trials, supply chain and other third-party providers and development and discovery operations; determinations made by European regulatory authorities or other regulatory authorities; 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-K for the quarter ending December 31, 2021. 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.
8 Pemazyre(pemigatinib) [Package Insert]. Wilmington, DE: Incyte; 2020.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
Tel: +1 302 498 6171
Tel: + 41 21 343 3113
Tel: +1 302 274 4773
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
Prosus FAQ's Regarding the Voluntary Share Exchange Offer to the Holders of Naspers N Ordinary Shares30.7.2021 19:00:00 CEST | Press release
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN OR INTO ANY JURISDICTION IN WHICH SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE PROHIBITED BY APPLICABLE LAW. PLEASE SEE THE IMPORTANT DISCLAIMERS AT THE END OF THIS ANNOUNCEMENT. Shareholders are referred to the prospectus (Prospectus) published by Prosus N.V. (Prosus) on 12 July 2021 in respect of the voluntary share exchange offer by Prosus to Naspers (JSE:NPN) (LSE:NPSN) N Shareholders (Exchange Offer). Further to the announcement issued by Prosus today, shareholders are advised that since the publication of the Prospectus Prosus has received certain frequently asked questions regarding the Exchange Offer and has therefore made certain materials available today at www.share-exchange-offer.com, where these frequently asked questions have been addressed by Prosus. Cape Town South Africa 30 July 2021 About Naspers Established in 1915, Naspers has transformed itself to become a global consumer internet compan
Prosus FAQ's Regarding the Voluntary Share Exchange Offer to the Holders of Naspers N Ordinary Shares30.7.2021 18:59:00 CEST | Press release
Shareholders are referred to the prospectus (Prospectus) published by Prosus on 12 July 2021 in respect of the voluntary share exchange offer by Prosus to Naspers N Shareholders (Exchange Offer). Since the publication of the Prospectus Prosus has received certain frequently asked questions regarding the Exchange Offer and has therefore made certain materials available today at www.share-exchange-offer.com, where these frequently asked questions have been addressed. About Prosus Prosus is a global consumer internet group and one of the largest technology investors in the world. Operating and investing globally in markets with long-term growth potential, Prosus builds leading consumer internet companies that empower people and enrich communities. The group is focused on building meaningful businesses in the online classifieds, food delivery, payments and fintech, and education technology sectors in markets including India, Russia, and Brazil. Through its ventures team, Prosus invests in
I’mbesideyou Inc. Launched “UNION OF EMOTIONS” Service Using AI to Visualize Cheering Each Other Across National Borders30.7.2021 16:25:00 CEST | Press release
I’mbesideyou Inc. (Setagaya-ku, Tokyo CEO: Shozo Kamiya, hereinafter referred to as I'mbesideyou) launched the "UNION OF EMOTIONS" service on July 23, 2021, the opening day of an international sporting event. This is the first time we have been able to visualize people cheering each other with emotion analysis AI. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210730005404/en/ A visualization of the emotions of cheers flying around the world: Click on each cheer to learn more about that country. (Photo: Business Wire) More than 20,000 cheers have already been sent from more than 79 cities across more than 14 countries around the world, and the sight of the cheers flying across the globe has moved many people on social media. UNION OF EMOTIONS, is the world's first example of people's emotions connecting in real time across countries with the help of AI. It is scheduled to be available until August 8, when the closing ceremon
Palace Bidco Oy (“WSIP Bidco”) Has Received Necessary Regulatory Approval Concerning the Recommended Cash Offer to the Shareholders of Adapteo Plc (“Adapteo”)30.7.2021 14:23:00 CEST | Press release
This announcement is not an offer, whether directly or indirectly, in Australia, Canada, Hong Kong, Japan, New Zealand or South Africa or in any other jurisdiction where such offer pursuant to legislation and regulations in such relevant jurisdiction would be prohibited by applicable law. Shareholders not resident in Sweden or Finland who wish to accept the Offer (as defined below) must make inquiries concerning applicable legislation and possible tax consequences. Shareholders should refer to the offer restrictions included in the section titled “Important information” at the end of this announcement and in the offer document which was published on 23 June 2021. Shareholders in the United States should also refer to the section titled “Special notice to shareholders in the United States” at the end of this announcement and in the offer document. On 17 May 2021, WSIP Bidco, a private limited liability company formed on behalf of, and indirectly wholly owned by, West Street Global Infra
Taipei Exchange Launches Pioneer Stock Board to Support Innovative Enterprises30.7.2021 10:00:00 CEST | Press release
The Taipei Exchange, TPEx, launched Pioneer Stock Board (PSB) on July 20, 2021, which welcomed its first company on July 26. Pioneer Stock Board marks the evolution of the stock market into an innovation-friendly ecosystem. It aims to facilitate entry to capital markets for more innovative enterprises. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210730005008/en/ Taipei Exchange launches Pioneer Stock Board to support innovative enterprises (Photo: Business Wire) At the PSB Launch Ceremony, Premier Su Tseng-chang delivered the opening speech, emphasizing the government’s support. Su said, “Taiwan’s capital market breaks new ground today, by establishing this board. PSB will support innovative enterprises, a key driver of economic transformation, by providing companies with quick access to capital needed for continued growth.” Dr. Tien-mu Huang, Chairperson of Financial Supervisory Commission, remarked, “Innovation underpin
ITRS Group Continues Expansion With the Acquisition Of Opsview30.7.2021 10:00:00 CEST | Press release
ITRS Group, a leading provider of real-time monitoring and analytics software, has acquired 100% of Opsview Limited, a modern, scalable monitoring platform, which provides unified insight into dynamic IT operations on-premises, in the Cloud or hybrid. Opsview will remain and operate as a separate brand and entity. The purchase of Opsview aligns well with ITRS’ strategy to build, buy and partner to deliver smart, automated and predictive end-to-end monitoring solutions for increasingly complex IT estates across industries. This development follows the successful strategic acquisitions of Sumerian, OP5 and Uptrends. Guy Warren, CEO of ITRS commented: “Opsview is trusted by hundreds of businesses, government organisations and service providers globally. This acquisition will enhance our technological innovation, increase our portfolio capability, and provide continued expansion across our global support services.” Mike Walton, CEO and founder of Opsview said: “Partnering with ITRS represe
Schneider Electric Moves Forward With Its Sustainability Impact Targets, Mobilizing Support From Employees, Partners and Customers30.7.2021 08:32:00 CEST | Press release
Schneider Electric, the leader in the digital transformation of energy management and automation, published today its half-year progress overview on setting up and advancing on its 2021-2025 sustainability impact targets. Schneider Electric, named as the world’s most sustainable corporation 2021 by the Corporate Knights Global 100 Index, announced the acceleration of its sustainability strategy in January, aligned to its commitments regarding climate, resources, trust, equal opportunities, generations, and local communities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210729006295/en/ Schneider Sustainability Impact - H1 Results (Graphic: Business Wire) Since then, the Group has successfully launched The Zero Carbon Project, its initiative to halve carbon emissions of its top supply chain partners by 2025, a call to action already joined by 91% of them. By engaging, training, and supporting the sustainable transformation
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