Incyte (NASDAQ: INCY) today announced that Health Canada has granted a Notice of Compliance with conditions for Pemazyre® (pemigatinib), a selective fibroblast growth factor receptor (FGFR) inhibitor, 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.
| MONTREAL, Sept. 17, 2021 /CNW/ - Incyte Corporation (NASDAQ: INCY) today announced that Health Canada has granted a Notice of Compliance with conditions for Pemazyre® (pemigatinib), a selective fibroblast growth factor receptor (FGFR) inhibitor, 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. “For appropriate patients with cholangiocarcinoma, the approval of Pemazyre in Canada offers patients hope with a new potential treatment option after their cancer has returned, following the failure of first-line treatment,” said Durhane Wong-Rieger, Ph.D., President and CEO, Canadian Organization for Rare Disorders. “Cholangiocarcinoma is a rare cancer of the bile duct with limited treatment options. As a result, patients face a poor prognosis,” said Dr. Vincent Tam, MD, Medical Oncologist, Tom Baker Cancer Centre. “With the approval of Pemazyre, we now have a targeted treatment option for those patients with progressive disease after first-line chemotherapy.” The conditional approval is based on data from the FIGHT-202 study evaluating pemigatinib as a treatment for patients with previously treated, locally advanced or metastatic cholangiocarcinoma. Study results demonstrated that in patients harbouring FGFR2 fusions or rearrangements (Cohort A), pemigatinib monotherapy resulted in an overall response rate (ORR) of 35.5 percent (primary endpoint) and median duration of response (DOR) of 9.1 months (secondary endpoint) with a median follow-up of 15.4 months. Adverse events observed included serous retinal detachment (SRD) and hyperphosphatemia. The most common adverse reactions (incidence ≥15%) are hyperphosphatemia, alopecia, diarrhea, fatigue, nail toxicity, dysgeusia, nausea, constipation, stomatitis, dry mouth, decreased appetite, vomiting, dry eye, arthralgia, abdominal pain, hypophosphatemia, dry skin, edema peripheral, weight decreased, headache, urinary tract infection, dehydration, hypercalcemia, and palmar-plantar erythrodysaesthesia syndrome. “We are pleased that Health Canada has granted conditional marketing authorization for Pemazyre and Incyte welcomes the opportunity to serve the cholangiocarcinoma community with this much-needed treatment option,” said Josée Brisebois, Ph.D.., Head of Medical Affairs, Incyte Biosciences Canada. “Incyte will strive to secure rapid access across Canada to this innovative targeted therapy to patients suffering from this difficult disease.” Cholangiocarcinoma is a rare cancer that forms in the bile duct. It is classified based on its anatomical 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.1,2 The incidence of cholangiocarcinoma varies regionally and ranges between 0.3-3.4 per 100,000 in North America and Europe.1 FGFR2 fusions or rearrangements occur almost exclusively in iCCA, where they are observed in 10-16% of patients.3,4,5,6 FGFRs play an important role in tumour 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. About FIGHT-202 The primary endpoint of FIGHT-202 was 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; and duration of response (DOR). For more information about FIGHT-202, visit https://clinicaltrials.gov/ct2/show/NCT02924376. About FIGHT About Pemazyre® (pemigatinib) In the United States, Pemazyre is approved for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement as detected by an FDA-approved test. 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. About Incyte To learn more about Incyte Biosciences Canada, visit https://incytebiosciences.ca. 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; determinations made by Canadian regulatory authorities or other regulatory authorities, including the 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; and other risks detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission, including its annual report for the year ended December 31, 2020, and the quarterly report on Form 10-Q for the quarter ended June 30, 2021. The Company disclaims any intent or obligation to update these forward-looking statements.
SOURCE Incyte Biosciences Canada | ||||||||||||||||
Company Codes: NASDAQ-NMS:INCY | ||||||||||||||||