Tumour invasion into a vein in a case of colorectal cancer. Credit: Patho / commons.wikimedia.org.

The US Food and Drug Administration (FDA) has accepted Taiho Oncology and Taiho Pharmaceutical’s supplemental new drug application (sNDA) of the colorectal cancer therapy trifluridine/tipiracil (LONSURF) for priority review.

The sNDA has been submitted for use of LONSURF as monotherapy or along with bevacizumab to treat adult patients with metastatic colorectal cancer (mCRC).

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

These patients were previously treated with fluoropyrimidine-based, oxaliplatin-based and irinotecan-based chemotherapy and an anti-EGFR therapy.

Discovered and developed by Taiho Pharmaceutical, LONSURF is an oral nucleoside antitumour agent comprising a thymidine-based nucleoside analogue trifluridine and the thymidine phosphorylase (TP) inhibitor tipiracil.

Taiho Oncology clinical development vice-president Dr Volker Wacheck stated: “We believe the combination of trifluridine/tipiracil plus bevacizumab may represent a significant advance in the treatment of refractory disease, and we look forward to working with the FDA as it considers this application.”

The submission of the sNDA is supported by data from the pivotal Phase III SUNLIGHT study, which showed that the investigational combination of trifluridine/tipiracil and bevacizumab offered improvements in overall survival (OS) and progression-free survival (PFS) for refractory mCRC patients.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The multinational, randomised, active-controlled, open-label and two-arm study was designed to assess the efficacy and safety of trifluridine/tipiracil plus bevacizumab against trifluridine/tipiracil alone.

The trial randomised 492 patients in a 1:1 ratio to receive trifluridine/tipiracil along with bevacizumab, or trifluridine/tipiracil monotherapy.

The primary objective was to evaluate the two treatments in terms of OS. PFS, overall response rate, disease control rate and quality of life were the key secondary endpoints.