EC Approves New Indication for Teysuno to Address Hand-Foot Syndrome and Cardiotoxicity

Nordic Pharma announced on the January 24 that the European Commission (EC) approved the new indication for Teysuno® (tegafur/gimeracil/oteracil) for the treatment of patients with metastatic colorectal cancer who cannot continue fluoropyrimidine treatment due to specific toxicities: hand-foot syndrome and cardiotoxicity. Nordic Pharma licenses Teysuno (known as TS-1 in Japan) from Taiho Pharmaceutical Co., Ltd. in Japan.  

Teysuno is currently indicated for treatment of advanced gastric cancer when given in combination with cisplatin (current indication). Alternatively, as monotherapy or in combination with oxaliplatin or irinotecan for the treatment of patients with metastatic colorectal cancer for whom it is not possible to continue treatment with another fluoropyrimidine due to hand-foot syndrome or cardiovascular toxicity.

Nordic Pharma received a positive scientific opinion recommending approval of the use of Teysuno in metastatic colorectal cancer from EMA’s Committee for Medicinal Products for Human Use (CHMP) in December 2021.

Related Article: Colorectal Cancer: An Outlook on the Disease and Treatments

Hand-Foot Syndrome and Cardiotoxicity

Hand foot syndrome (palmar-plantar erythrodysesthesia) is a condition induced by fluoropyrimidine chemotherapy that causes redness on the palm side of the hands and soles of the feet. This redness can also come with sensitivity and soreness as well as peeling and blisters like a sunburn. This painful condition, like cardiotoxicity, occurs in a certain percentage of total cancer patients taking fluoropyrimidines.

Cardiotoxicity is a much more serious side effect of fluoropyrimidines that can lead to heart failure if left unchecked. Affecting between 1 and 19% of patients this affliction comes with cases of arrhythmia, angina and ischemia. In cases of these illnesses the common recommendation is to immediately stop the chemotherapy regimen and reassess possible medications to use. While it is advisable to avoid heart disease it does still leave the patient with the significant problem of needing to stop and find a new treatment for their cancer.

Iris van Lakerveld, Global Oncology Lead added: “Fluoropyrimidines are, and will continue to be, the cornerstone of chemotherapy treatment in metastatic colorectal cancer. A significant group of patients can now be offered an alternative, in the event that chemotherapy needs to be delayed, the dose reduced or fully stopped because of hand-foot syndrome or cardiotoxicity. Side effects with chemotherapy are inevitable. With Teysuno, physicians and patients will have an additional therapy when needed, allowing optimal benefit of fluoropyrimidine treatment.”

Related Article: How Patients with dMMR/MSI-H Tumors Can Benefit from Immunotherapy?

Cancer Market

Before Teysuno was approved both for colorectal cancer it primarily worked for gastric cancer. The disease had an estimated 783,000 deaths in 2018 while colorectal cancer had approximately 1 million deaths and 2 million new cases of colorectal cancer in the same year. Both of these numbers are for total deaths globally.

 Colorectal cancer is the 3rd most common amongst both men and women and has a much larger footprint when compared to gastric cancer. This much larger number of patients creates an opportunity for Nordic Pharma.

Nordic Pharma’s Plans

Nordic Pharma is a medium-sized pharma with a focus on the development and commercialization of specialty products like niche hospital and orphan products. So it is fitting that they take advantage of the new use for an existing cancer drug for a different kind of cancer.

In metastatic colorectal cancer the typical first-line chemotherapy consists of a fluoropyrimidine used in various combinations. On the other side of the coin that does mean the cardiotoxicity will be incredibly common and so a strong need for an alternative.

Teysuno is an oral fluoropyrimidine with similar efficacy, but improved specific safety profile compared with other fluoropyrimidines.

Author

Eduardo Longoria