PEMAZYRE Drug Insight

"PEMAZYRE Market Size, Forecast, and Drug Insight – 2032” report provides comprehensive insights about PEMAZYRE for Cholangiocarcinoma (CCA) in the seven major markets. A detailed picture of the PEMAZYRE for Cholangiocarcinoma  in the 7MM, i.e., the United States, EU4 (Germany, France, Italy and Spain) and the United Kingdom, and Japan for the study period 2019–2032 is provided in this report along with a detailed description of the PEMAZYRE for Cholangiocarcinoma.The report provides insight about mechanism of action, dosage and administration, as well as research and development activity including regulatory milestones, along with other developmental activities. Further, it also consists of future market assessments inclusive of the PEMAZYRE market forecast, analysis for Cholangiocarcinoma in the 7MM descriptive analysis such as SWOT, analyst views, comprehensive overview of market competitors, and brief about other emerging therapies in Cholangiocarcinoma.

Drug Summary

PEMAZYRE (pemigatinib) is an orally bioavailable inhibitor of the fibroblast growth factor receptor (FGFR) types 1, 2, and 3 (FGFR1/2/3), with potential antineoplastic activity. It binds to and inhibits FGFR1/2/3, which may result in the inhibition of FGFR1/2/3-related signal transduction pathways; this inhibits proliferation in FGFR1/2/3-overexpressing tumor cells. FGFR, a family of receptor tyrosine kinases upregulated in many tumor cell types, plays a key role in cellular proliferation, migration, and survival.

PEMAZYRE is indicated for treating adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or another rearrangement as detected by an FDA-approved test.

• Dosage and Administration

The Recommended dosage is 13.5 mg orally once daily for 14 consecutive days, followed by 7 days off therapy in 21-day cycles. Continue treatment until disease progression or unacceptable toxicity occurs.

• Mechanism of Action

Pemigatinib is a small molecule kinase inhibitor that targets FGFR1, 2 and 3 with IC50 values of less than 2 nM. Pemigatinib also inhibited FGFR4 in vitro at a concentration approximately 100 times higher than those that inhibit FGFR1, 2, and 3. Pemigatinib inhibited FGFR1-3 phosphorylation and signaling and decreased cell viability in cancer cell lines with activating FGFR amplifications and fusions that resulted in constitutive activation of FGFR signaling. Constitutive FGFR signaling can support the proliferation and survival of malignant cells. Pemigatinib exhibited anti-tumor activity in mouse xenograft models of human tumors with FGFR1, FGFR2, or FGFR3 alterations resulting in constitutive FGFR activation including a patient-derived xenograft model of cholangiocarcinoma that expressed an oncogenic FGFR2- Transformer-2 beta homolog (TRA2b) fusion protein.

Scope of the Report

The report provides insights into:

• A comprehensive product overview including the PEMAZYRE description, mechanism of action, dosage and administration, research and development activities in Cholangiocarcinoma.
• Elaborated details on PEMAZYRE regulatory milestones and other development activities have been provided in this report.
• The report also highlights the PEMAZYRE research and development activity in Cholangiocarcinoma in detail across the United States, Europe and Japan.
• The report also covers the patents information with expiry timeline around PEMAZYRE.
• The report contains forecasted sales of PEMAZYRE for Cholangiocarcinoma till 2032.
• Comprehensive coverage of the late-stage emerging therapies for Cholangiocarcinoma.
• The report also features the SWOT analysis with analyst views for PEMAZYRE in Cholangiocarcinoma.

Methodology

The report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight’s team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

PEMAZYRE Analytical Perspective by DelveInsight

• In-depth PEMAZYRE Market Assessment

This report provides a detailed market assessment of PEMAZYRE in Cholangiocarcinoma in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides forecasted sales data from 2023 to 2032.

• PEMAZYRE Clinical Assessment

The report provides the clinical trials information of PEMAZYRE in Cholangiocarcinoma covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights 

• In the coming years, the market scenario for Cholangiocarcinoma is set to change due to the extensive research and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.  
• The companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence PEMAZYRE dominance.
• Other emerging products for Cholangiocarcinoma are expected to give tough market competition to PEMAZYRE and launch of late-stage emerging therapies in the near future will significantly impact the market.
• A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of PEMAZYRE in Cholangiocarcinoma.
• Our in-depth analysis of the forecasted sales data from 2023 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the PEMAZYRE in Cholangiocarcinoma.

Key Questions

• What is the product type, route of administration and mechanism of action of PEMAZYRE?
• What is the clinical trial status of the study related to PEMAZYRE in Cholangiocarcinoma and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the PEMAZYRE development?
• What are the key designations that have been granted to PEMAZYRE for Cholangiocarcinoma?
• What is the forecasted market scenario of PEMAZYRE for Cholangiocarcinoma?
• What are the forecasted sales of PEMAZYRE in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain, and the United Kingdom), and Japan? 
• What are the other emerging products available in Cholangiocarcinoma and how are they giving competition to PEMAZYRE for Cholangiocarcinoma?
• Which are the late-stage emerging therapies under development for the treatment of Cholangiocarcinoma?