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Positive EMA opinion för Teysuno

Nordic Pharma meddelar att CHMP gett ett positivt utlåtande för Teysuno för behandling av patienter med metastaserande kolorektalcancer

Nordic Pharma has announced that on 16 December 2021, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion Teysuno: Pending EC decision | European Medicines Agency (] recommending the use of 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.
The CHMP supports including patients who developed these toxicities in the adjuvant setting in addition to metastatic patients.

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

Based on this positive opinion, Teysuno will be indicated in adults:

  • for the treatment of advanced gastric cancer when given in combination with cisplatin (current indication).
  • as monotherapy or in combination with oxaliplatin or irinotecan, with or without bevacizumab, 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 that developed in the adjuvant or metastatic setting (pending European Committee decision).

New fluoropyrimidine for patients with metastatic colorectal cancer

In metastatic colorectal cancer, the typical first-line chemotherapy contains of a fluoropyrimidine used in various combinations.

Jean-Michel Quinot, CEO of Nordic Pharma stated: ”This is important news for patients with metastatic colorectal cancer. Teysuno offers those patients suffering from toxicities that can cause discontinuation of therapy; an alternative fluoropyrimidine therapy which allows them to continue systemic treatment that is known to significantly prolong survival. By being able to meet this medical need, we hope to contribute to improving the lives of these patients. We want to particularly thank medical oncologists and patients in different European countries who contributed to collecting crucial clinical data for this new indication.”

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.

Nordic Pharma has licenced Teysuno® from Taiho Pharmaceutical Co., Ltd. in Japan. In Japan, the product is known as TS-1 and is approved for various solid tumours, including gastric and colorectal cancer. Since 2011, Teysuno has been on the European market in 17 countries. In total, the product is marketed in over 30 countries worldwide.

This positive CHMP opinion is a first step in providing patients with metastatic colorectal cancer access to Teysuno. EMA’s opinion needs to be adopted by the European Commission, and subsequently country-specific reimbursement applications will be done at the level of each Member State to ensure this access.

About Nordic Pharma

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