Incyte announces the approval of Pemazyre® (pemigatinib) in Japan for the treatment of patients with unresectable bile duct cancer (BTC) with a fibroblast growth factor receptor 2 (FGFR2) fusion gene, s ” aggravating after cancer chemotherapy
Incyte (Nasdaq: INCY) today announced that Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved Pemazyre® (pemigatinib), a selective fibroblast growth factor receptor (FGFR) inhibitor, for the treatment of patients with unresectable bile duct cancer (BTC) with a human growth factor receptor 2 fusion gene. fibroblasts (FGFR2)1, worsening after cancer chemotherapy.
“Pemazyre’s MHLW approval is a significant milestone for the BTC community and underscores our commitment to finding and delivering solutions to patients with significant unmet medical needs,” said Lothar Finke, MD, Ph.D., director General of Incyte Asia. “BTC is a rare and serious disease, and we are proud to be able, with the support of MHLW, to bring a new targeted treatment to more patients around the world. “
BTC is a rare cancer that forms in the bile ducts. Cholangiocarcinoma, a subtype of CTB, is classified according to its origin: intrahepatic, which occurs in the bile ducts inside the liver, and extrahepatic, which occurs in the bile ducts outside the liver. Patients with BTC are often diagnosed late or advanced when the prognosis is poor2.3. FGFR2 fusions or rearrangements, which occur almost exclusively in intrahepatic cholangiocarcinoma, are seen in a small percentage of Japanese patients with BTC4,5,6,7.
The approval 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. In FIGHT-202 patients harboring FGFR2 fusions or rearrangements (cohort A), Pemazyre monotherapy resulted in an overall response rate of 36% (primary endpoint) and a median ORD of 7.49 months (secondary endpoint) . The most common treatment-related adverse event (TRE) was hyperphosphatemia grade ≤ 2 (58.2%). Other common adverse reactions (all grades combined) observed in ≥ 30% of patients were alopecia, diarrhea, fatigue, dysgeusia, nausea, constipation, stomatitis, dry mouth and decreased blood pressure. ‘appetite. The majority of these AEIs were grade ≤2. Grade ≥ 3 TIA that occurred in ≥ 10% of patients was hypophosphatemia.
Previously, the MHLW had granted orphan drug designation to Pemazyre – a designation given to investigational compounds intended to treat rare diseases that affect fewer than 50,000 people in Japan and for which there is a high medical need.8. Designated orphan drugs are eligible for priority review of marketing authorizations in order to ensure their supply in clinical settings as soon as possible.8.
The FIGHT-202, open-label, phase 2, multicenter study (NCT02924376) evaluates the safety and efficacy of pemigatinib – a selective inhibitor of the fibroblast growth factor receptor (FGFR) 1, 2, 3 – in adult patients ( age ≥ 18 years) with previously treated locally advanced or metastatic cholangiocarcinoma with documented FGF / FGFR status.
The patients were included in 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 of oral pemigatinib once daily (QD) over a 21-day cycle (two weeks treatment / one week rest) until radiologic disease progression or unacceptable toxicity.
The primary endpoint of FIGHT-202 is the overall response rate (ORR) in cohort A, assessed by independent review according to 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 on FIGHT-202, visit https://clinicaltrials.gov/ct2/show/NCT02924376.
The fight (FIbroblast gRowth factor receptor in oncology and Hematology Trials) includes ongoing Phase 2 and 3 studies on the safety and efficacy of pemigatinib treatment in several FGFR-induced 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 FGFR3 mutations or activating 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 unresectable solid malignancies with activating FGFR mutations or fusions / rearrangements, regardless of tumor type.
FIGHT-302 is a phase 3 study of pemigatinib 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 cholangiocarcinoma or metastatic with fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement detected by an FDA approved test.9. This indication is approved under expedited approval based on overall response rate and duration of response. Continued approval for this indication may depend on verification and description of clinical benefit in one or more confirmatory trials.
In Japan, Pemazyre is approved for the treatment of patients with unresectable bile duct cancer (BTC) with a fibroblast growth factor receptor 2 (FGFR2) fusion gene, which gets worse after cancer chemotherapy.
Pemazyre is a potent and selective oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacological activity against cancer cells with FGFR alterations.
Pemazyre is marketed by Incyte in the United States and will be marketed by Incyte in Japan. Incyte has granted Innovent Biologics, Inc. the rights to develop and commercialize pemigatinib in hematology and oncology in mainland China, Hong Kong, Macau and Taiwan. Incyte retained all other rights to develop and commercialize pemigatinib outside of the United States.
In addition, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a favorable opinion recommending the conditional marketing authorization of pemigatinib for the treatment of adults with cholangiocarcinoma. locally advanced or metastatic with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that has progressed after at least one prior line of systemic therapy.
Pemazyre is a trademark of Incyte Corporation.
Incyte is a global biopharmaceutical company based in Wilmington, Delaware, focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary treatments. For more information on Incyte, please visit Incyte.com and follow @Incyte.
For more information on Incyte Biosciences Japan GK, please visit Incyte.jp.
Except for historical information set forth herein, the matters set forth in this press release, including statements regarding whether and / or when Pemazyre could provide a treatment option for patients with locally advanced cholangiocarcinoma or metastatic positive at FGFR fusion, and the subsequent development of pemigatinib, contain predictions, estimates and other forward-looking statements.
These forward-looking statements are based on the Company’s current expectations and are subject to risks and uncertainties which may cause actual results to differ materially, including unforeseen developments and risks related to: unforeseen delays; the pursuit of research and development and the results of clinical trials which may be unsuccessful or insufficient to meet applicable regulatory standards or justify further development; the ability to enroll a sufficient number of subjects in clinical trials and the ability to enroll subjects according to scheduled schedules; the effects of the COVID-19 pandemic and pandemic response measures on clinical trials, the supply chain and other third party vendors as well as the Company’s development and discovery operations; decisions made by the FDA, EMA, PMDA or MHLW and other regulatory authorities; the Company’s dependence on its relations with its collaborative partners; the effectiveness or safety of the Company’s products and the products of the Company’s collaborative partners; market acceptance of the Company’s products and the products of the Company’s collaborative partners; competition in the market; sales, marketing, manufacturing and distribution requirements; spending higher than forecast; expenses related 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 year ended December 31, 2020. The Company disclaims any intention or obligation to update these forward-looking statements.
The drug information contained herein is intended for the disclosure of Incyte’s corporate information and is not intended to advertise or promote any drug, including those under development.
1 In the approved Japanese indication, the “fusion gene” includes both fusion genes and rearrangements.
2 Banales JM, et al. Nat Rev Gastroenterol Hepatol. 2016; 13: 261‒280.
3 Uhlig J, et al. Ann Surg Oncol. 2019; 26: 1993-2000.
4 White Paper on Liver Cancer 2015. Japanese Society of Hepatology.
5 Nakamura H, et al. Nat Genet. 2015; 47: 10031010.
6 Jang H, et al. J Gastroenterol. 2020; 26: 6207-6223.
7 Japan Liver Cancer Study Group Follow-up Investigation Committee. The 20th national primary liver cancer follow-up report (2008-2009). Liver. 2019; 60: 258-293.
8 Presentation of the designation system for orphan drugs / medical devices. Ministry of Health, Labor and Welfare. Available at: https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000068484.html.
9 Pemazyre (pemigatinib) [Package Insert]. Wilmington, DE: Incyte; 2020.
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