Pemigatinib

Incyte Announces Japanese Approval of Pemazyre® (pemigatinib) for the Treatment of Patients with Myeloid/Lymphoid Neoplasms (MLNs)

Retrieved on: 
Monday, March 27, 2023

“The MHLW approval of Pemazyre in MLNs is an important step toward potentially providing a therapeutic option for Japanese patients with this rare condition,” said Lothar Finke, M.D., Ph.D., Group Vice President and General Manager, Incyte Asia.

Key Points: 
  • “The MHLW approval of Pemazyre in MLNs is an important step toward potentially providing a therapeutic option for Japanese patients with this rare condition,” said Lothar Finke, M.D., Ph.D., Group Vice President and General Manager, Incyte Asia.
  • The primary endpoint, investigator-assessed complete response rate, was 62.5% (95% CI: 45.8 - 77.3).
  • The most common adverse reactions observed in patients receiving Pemazyre were hyperphosphatemia (70.7%), alopecia (56.1%), diarrhea (43.9%) and stomatitis (43.9%).
  • Designated orphan drugs are also eligible for priority review for marketing authorizations to ensure supply to clinical settings at the earliest opportunity1.

Incyte Announces Data from Across its Oncology Portfolio will be Presented at the AACR Annual Meeting 2023

Retrieved on: 
Tuesday, March 14, 2023

Incyte (Nasdaq:INCY) today announced that multiple abstracts from across its oncology portfolio will be presented during the upcoming American Association for Cancer Research (AACR) Annual Meeting 2023, held April 14-19, in Orlando, Florida.

Key Points: 
  • Incyte (Nasdaq:INCY) today announced that multiple abstracts from across its oncology portfolio will be presented during the upcoming American Association for Cancer Research (AACR) Annual Meeting 2023, held April 14-19, in Orlando, Florida.
  • ET)
    Five-Year Safety and Efficacy of Tafasitamab in Patients with Relapsed or Refractory DLBCL: Final Results from the Phase 2 L-MIND Study1(Abstract #CT022.
  • ET)
    For registered attendees, the virtual meeting platform and all on-demand sessions will be available through July 19, 2023.
  • More information regarding the AACR Annual Meeting 2023 can be found at https://www.aacr.org/meeting/aacr-annual-meeting-2023/ .

Fibroblast Growth Factor Receptor 4 (FGFR4) Antagonist Market Insights 2022: Coverage of 15 Companies and Respective Pipeline Drugs - ResearchAndMarkets.com

Retrieved on: 
Wednesday, June 29, 2022

This Fibroblast Growth Factor Receptor 4 (FGFR4) Antagonist - Pipeline Insight, 2022 report provides comprehensive insights about 15+ companies and 15+ pipeline drugs in Fibroblast Growth Factor Receptor 4 (FGFR4) Antagonist pipeline landscape.

Key Points: 
  • This Fibroblast Growth Factor Receptor 4 (FGFR4) Antagonist - Pipeline Insight, 2022 report provides comprehensive insights about 15+ companies and 15+ pipeline drugs in Fibroblast Growth Factor Receptor 4 (FGFR4) Antagonist pipeline landscape.
  • The companies and academics are working to assess challenges and seek opportunities that could influence R&D Fibroblast Growth Factor Receptor 4 (FGFR4) Antagonist.
  • Fibroblast Growth Factor Receptor 4 (FGFR4) Antagonist: Therapeutic Assessment
    This segment of the report provides insights about the Fibroblast Growth Factor Receptor 4 (FGFR4) Antagonist drugs segregated based on following parameters that define the scope of the report, such as:
    There are approx.
  • The companies which have their Fibroblast Growth Factor Receptor 4 (FGFR4) Antagonist drug candidates in the most advanced stage, i.e Phase III include, Helsinn.

Biliary Tract Cancer Market Spotlight Report 2021 - ResearchAndMarkets.com

Retrieved on: 
Thursday, January 27, 2022

The "Market Spotlight: Biliary Tract Cancer" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Market Spotlight: Biliary Tract Cancer" report has been added to ResearchAndMarkets.com's offering.
  • Biliary tract cancer (BTC), also known as cholangiocarcinoma or bile duct adenocarcinoma, is a cancer that originates from the cells which line the bile duct.
  • The publisher estimates that in 2019, there were approximately 405,800 incident cases of biliary tract cancer (BTC) worldwide, and forecasts that number to increase to 433,300 incident cases by 2028.
  • AstraZeneca leads industry sponsors with the highest overall number of clinical trials for biliary tract neoplasms.

Specialised Therapeutics Enters into a New Supply and Distribution Agreement with Incyte to Launch Two New Cancer Therapies, Tafasitamab and Pemigatinib, in Australia, New Zealand and Singapore

Retrieved on: 
Friday, October 22, 2021

SINGAPORE, Oct. 21, 2021 /PRNewswire/ -- Independent pharmaceutical company Specialised Therapeutics Asia Pte Ltd (ST) will partner with Incyte Biosciences International Sàrl, the Swiss-based affiliate of Incyte (NASDAQ:INCY), to launch and distribute two new medicines for its haematology and oncology portfolios, tafasitamab (sold as Monjuvi® in the United States and Minjuvi® in Europe) and pemigatinib (Pemazyre®).

Key Points: 
  • "Both pemigatinib and tafasitamab address strong unmet needs in rare patient populations.
  • Our teams look forward to working closely with Incyte to ensure all eligible patients have access to these therapies at the earliest opportunity."
  • "We look forward to a successful and mutually beneficial partnership, working together with a shared goal of improving patient outcomes."
  • In January 2020, MorphoSys and Incyte entered into a Collaboration and License agreement to further develop and commercialize tafasitamab globally.

Knight Therapeutics Enters into Exclusive Supply and Distribution Agreement with Incyte for Tafasitamab and Pemigatinib in Latin America

Retrieved on: 
Thursday, September 23, 2021

Under the terms of the agreement, Incyte will be responsible for the development, manufacture and supply to Knight of tafasitamab and pemigatinib, and Knight will be responsible for seeking the necessary regulatory approvals and distributing both medicines in Latin America.

Key Points: 
  • Under the terms of the agreement, Incyte will be responsible for the development, manufacture and supply to Knight of tafasitamab and pemigatinib, and Knight will be responsible for seeking the necessary regulatory approvals and distributing both medicines in Latin America.
  • We are delighted to partner with Incyte, a leading global biopharmaceutical company, to bring tafasitamab and pemigatinib to patients in Latin America upon approval, said Samira Sakhia, President and Chief Executive Officer of Knight.
  • We are eager to work together to expand access to tafasitamab and pemigatinib so that eligible patients in Latin America have access to these innovative medicines.
  • In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally.

Global Fibroblast Growth Factor Receptor Inhibitor Drug Market to 2026 - Opportunity & Clinical Trials Insights - ResearchAndMarkets.com

Retrieved on: 
Friday, August 13, 2021

Global Fibroblast Growth Factor Receptor Inhibitor Drug Market Opportunity & Clinical Trials Insight 2026 Report Highlights:

Key Points: 
  • Global Fibroblast Growth Factor Receptor Inhibitor Drug Market Opportunity & Clinical Trials Insight 2026 Report Highlights:
    Global FGFR Inhibitors Market Opportunity: > USD 4 Billion by 2026
    Clinical & Sales Insight on Approved FGFR Inhibitors: 3 (Belvesra, Pemazyre & Truseltiq)
    Comprehensive Clinical Trials Insight by Company, Country, Phase & Patient Segment: 53 Drugs in Trials
    Recent breakthrough with respect to small molecule-based therapy in the oncology segment has set up remarkable achievements in terms of improving the cancer survival rate.
  • Currently, the market of FGFR inhibitors is at nascent stage, which is driven by the sales of 3 approved products of this class i.e.
  • Many new drugs of this class are also believed to get orphan designation in upcoming years, which further boost the market size of this segment.
  • Further, US will lead the FGFR market due to the availability of a huge cancer burden and leading pharmaceutical companies.

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

Retrieved on: 
Monday, March 29, 2021

Pemazyre offers a much-needed option to eligible patients that have only had few effective treatment options until today.

Key Points: 
  • Pemazyre offers a much-needed option to eligible patients that have only had few effective treatment options until today.
  • Historically, patients living with advanced cholangiocarcinoma have had very limited treatment options, said Helen Morement, CEO, AMMF The Cholangiocarcinoma Charity.
  • FIGHT-302 is a Phase 3 study investigating Pemazyre as a first-line treatment for patients with cholangiocarcinoma with FGFR2 fusions or rearrangements.
  • 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.

Incyte Announces Approval of Pemazyre® (pemigatinib) in Japan 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

Retrieved on: 
Tuesday, March 23, 2021

FGFR2 fusions or rearrangements, which occur almost exclusively in intrahepatic cholangiocarcinoma, are observed in a small percentage of Japanese patients with BTC4,5,6,7.

Key Points: 
  • FGFR2 fusions or rearrangements, which occur almost exclusively in intrahepatic cholangiocarcinoma, are observed in a small percentage of Japanese patients with BTC4,5,6,7.
  • Other frequent TEAEs (all grades) observed in 30% of patients were alopecia, diarrhea, fatigue, dysgeusia, nausea, constipation, stomatitis, dry mouth and decreased appetite.
  • 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.
  • Pemazyre is marketed by Incyte in the United States and will be marketed by Incyte in Japan.

Incyte Announces Positive CHMP Opinion for Pemigatinib for the Treatment of Adults With Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma With a Fibroblast Growth Factor Receptor 2 (FGFR2) Fusion or Rearrangement

Retrieved on: 
Friday, January 29, 2021

The CHMP opinion 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.

Key Points: 
  • The CHMP opinion 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.
  • If approved, pemigatinib will be the first targeted treatment in the EU indicated for patients with unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement and would be commercialized under the brand name Pemazyre.
  • Patients with cholangiocarcinoma are often diagnosed at a late or advanced stage when the prognosis is poor1,2.
  • FIGHT-302 is a Phase 3 study investigating pemigatinib as a first-line treatment for patients with cholangiocarcinoma with FGFR2 fusions or rearrangements.