Quebec is the First Province to Recommend that Pemazyre® (pemigatinib), a Targeted Treatment for Patients with Advanced Cholangiocarcinoma (CCA), be Listed on Public Formulary Français
- Decision confirms the therapeutic value of Pemazyre® (pemigatinib) and need for new approaches to treat advanced cholangiocarcinoma (bile duct cancer)
- INESSS positive recommendation is an important milestone towards public funding for eligible patients
MONTREAL, Dec. 4, 2023 /CNW/ - Incyte Biosciences Canada Corporation is pleased to announce that Quebec's health technology assessment agency, Institut national d'excellence en santé et services sociaux (INESSS), has issued a positive recommendation to list Pemazyre® (pemigatinib) on the public formulary. Pemazyre addresses an urgent medical need as the only targeted drug commercialized in Canada to treat cholangiocarcinoma (CCA) patients previously treated with systemic therapy, with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement. Full details on the recommendation by INESSS, including recommended criteria for reimbursement, are available on the INESSS website.i
"It is crucial for individuals grappling with this advanced disease to have timely access to approved treatment options potentially extending their lives and affording them more cherished moments with their loved ones," said Dr. Jamil Asselah, medical oncologist and associate professor at the McGill University Health Centre. "We are optimistic that INESSS's favourable recommendation will motivate the Quebec health authority to swiftly grant public access to this treatment, allowing eligible patients to derive the benefits from this therapy at the earliest opportunity."
INESSS Recommendationii
INESSS identified the importance, for patients and their families, of having access to different treatment options that enable them to reverse or control the disease and maintain a good quality of life. With an oral administration, Pemazyre may reduce the use of healthcare system resources since patients take this treatment at home. In contrast, patients who receive chemotherapy intravenously must go to the hospital potentially putting more strain on the healthcare system, the patient and their caregivers.
"It is encouraging to see a targeted medicine like Pemazyre, which was approved two years ago by Health Canada, be recommended for public funding. It is critical that patients have multiple treatment options available to them that specifically target their tumor types," said Melinda Bachini, Chief Patient Officer, The Cholangiocarcinoma Foundation (CCF) and CCA survivor. "While those of us working in patient advocacy are encouraged by this recommendation to provide public access in Quebec, we want all eligible cholangiocarcinoma patients in Canada to be afforded this hope and we will continue to advocate, putting patients first, so that they all have better therapeutic options."
In Canada, there are approximately 400 new CCA cases diagnosed each yeariii, the majority (70%) in advanced stages with unresectable, locally advanced or metastatic diseaseiv. There are two main subtypes of CCA: intrahepatic (iCCA) and extrahepatic (eCCA). The 5-year relative survival rates for iCCA and eCCA are only 9% and 10% respectivelyv and there are currently no routine screening tests to check for CCA before signs and symptoms occur.
One of the most frequent genetic alterations in iCCA patients involve the fibroblast growth factor receptor (FGFR) 2 (FGFR2)vi. The FGFR2 fusions or rearrangements are found in 10% to 20% of iCCA patientsvii. FGFRs play an important role in tumour cell proliferation and survival, migration, and angiogenesis (the formation of new blood vessels).
The INESSS recommendation for Pemazyre requires the identification of fusions or rearrangements of the FGFR2 gene through a companion diagnostic test which identifies patients who will benefit from this targeted therapy. Incyte Biosciences Canada provided a companion diagnostic test through a clinically accredited independent laboratory. This time-limited testing program has been available across Canada since 2021.
"We commend the Government of Quebec for their leadership in being the first health technology assessment agency to provide a positive recommendation to list Pemazyre and the companion test on their public formulary," said Christine Lennon, General Manager, Incyte Biosciences Canada. "This news is a positive step forward, and we will continue to work diligently with all regulatory authorities – including Cancer Agencies across Canada – so that any eligible patient in Canada who may benefit from this treatment can have access to it."
"In the 25 years that I have looked after biliary tract cancer patients, this drug represents one of the key scientific and clinical advancements as an effective targeted agent that gives patients another treatment for their advanced cancer, one that has few effective options," says Dr. Jennifer Knox, medical oncologist at the Princess Margaret Cancer Center and professor of medicine at the University of Toronto. "Without public funding our Canadian patients have fallen behind the international gold standard of care for this rare cancer with a poor prognosis. This positive INESSS recommendation is a step in the right direction, but we need the other provinces to follow quickly to enable access to this treatment across Canada."
Pemazyre is a kinase inhibitor indicated in Canada 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. Health Canada issued a Notice of Compliance with conditions for Pemazyre (pemigatinib) on September 17, 2021.
Pemazyre is marketed by Incyte in the United States, Canada, Europe and Japan.
Pemazyre is a registered trademark of 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.
To learn more about Incyte Biosciences Canada, visit https://incytebiosciences.ca.
Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding whether and when Pemazyre might be listed on the public formulary in Quebec or elsewhere in Canada, whether and when Pemazyre might provide a successful treatment option for patients with CCA and Incyte's ongoing clinical development program for pemigatinib, contain predictions, estimates and other forward-looking statements.
These forward-looking statements are based on Incyte'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; determinations made by Health Canada and other regulatory authorities; Incyte's dependence on its relationships with its collaboration partners; the efficacy or safety of Incyte's products and the products of its collaboration partners; the acceptance of Incyte's products and the products of its collaboration partners in the marketplace; market competition; sales, marketing, manufacturing, and distribution requirements; and other risks detailed from time to time in the Company's reports filed with the U.S. Securities and Exchange Commission, including its annual report and its quarterly report on Form 10-Q for the quarter ended September 30, 2023. Incyte disclaims any intent or obligation to update these forward-looking statements.
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iii Meza-Junco J, Montano-Loza AJ, Ma M, Wong W, Sawyer MB, Bain VG. Cholangiocarcinoma: has there been any progress? Canadian journal of gastroenterology = Journal canadien de gastroenterologie. 2010;24(1):52-57. |
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iv NICE. National Institute for Health and Care Excellence. Single Technology Appraisal. Pemigatinib for treating relapsed or refractory advanced cholangiocarcinoma with FGFR2 alterations [ID3740]. Committee Papers. 2021: https://www.nice.org.uk/guidance/ta722/documents/committee-papers-3. |
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v American Cancer Society. Survival Rates for Bile Duct Cancer ACCESSED: July 20, 2021. https://www.cancer.org/cancer/bile-duct-cancer/detection-diagnosis-staging/survival-by-stage.html. |
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vi NICE. National Institute for Health and Care Excellence. Single Technology Appraisal. Pemigatinib for treating relapsed or refractory advanced cholangiocarcinoma with FGFR2 alterations [ID3740]. Committee Papers. 2021: https://www.nice.org.uk/guidance/ta722/documents/committee-papers-3. |
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vii Lamarca A, Barriuso J, McNamara MG, Valle JW. Molecular targeted therapies: Ready for “prime time” in biliary tract cancer. J Hepatol. 2020;73(1):170-185. PubMed |
SOURCE Incyte Biosciences Canada
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