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FDA clears Taiho's oral colorectal cancer drug

Regulatory nod for Lonsurf gives patients additional treatment options
FDA

Patients with colorectal cancer in the US will soon have access to a new treatment option after the FDA approved a two-drug oral therapy developed by Taiho Oncology.

The go-ahead for Lonsurf - which combines the chemotherapy drug trifluridine with a boosting agent called tipiracil - provides another line of treatment for patients who are no longer responding to other therapies, according to the regulator.

Previously known as TAS-102, the fixed-dose combination makes trifluridine suitable for administration as a cancer drug for the first time - despite being discovered back in the 1960s.

The nucleoside analogue has previously been used as an antiviral therapy in Monarch Pharmaceuticals' Viroptic, but its use as a cancer drug was prevented by a very short half-life in the blood. By giving it alongside tipiracil, a thymidine phosphorylase inhibitor, its half-life is markedly increased.

Commenting on the approval, the FDA's head of haematology and oncology products, Richard Pazdur, said that while there have been significant advances in the detection and treatment of colorectal cancer in the last 10 years "there are many patients who still need additional options."

The approval is based on the results of the 800-patient RECOURSE trial, which showed that Lonsurf was able to achieve a significant 32% improvement in overall survival compared to placebo in patients receiving the drug as third- or fourth-line therapy.

Median survival in the study was 7.1 months with Taiho's drug, compared to 5.3 months with placebo. 

US approval is the first for Lonsurf outside Japan where it was given the nod in March 2014, according to Taiho Oncology, which is a subsidiary of Japan's Taiho Pharmaceutical. It is the first FDA approval for the US unit, which operates out of Princeton, New Jersey, and Lonsurf is also under review in Europe.

Lonsurf joins a number of other new drugs for advanced colorectal cancer, such as Eli Lilly's second-line injectable drug Cyramza (ramucirumab) and Boehringer Ingelheim's third/fourth-line product Vargatef (nintedanib).

The market is becoming increasingly crowded, according to IMS Health, which predicts "modest" sales for Taiho's drug given the relatively short survival span of patients who have failed other treatments. However, as an oral drug its pricing is expected to be "competitive" compared to its rivals.

Article by
Phil Taylor

23rd September 2015

From: Research

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