FDA Approved a Combo Drug (Lonsurf) for Gastric Cancer

The report on Lonsurf  was published on the official website of U.S Food and Drug Administration.

Gastric adenocarcinoma is a type of stomach cancer and is considered the second most common cancer in the world. According to reports, the combined drug Lonsurf  can cure those patients who are suffering from gastric adenocarcinoma.

Gastric cancer is the fifth most common cancer in the world and the third leading cause of cancer deaths (after lung and liver cancer) with about 723,000 deaths a year.

In recent years, the result in gastric cancer has improved dramatically, and survival has increased dramatically over the last 10 years. With the advancement of cancer, but can limit many drug-usable complications and rule out intensive chemotherapy. The extension of survival and alleviate the symptoms of advanced treatment of metastatic gastric cancer are problems for which it is considered important to increase the possibilities of new therapeutic drugs. At present recommended for metastatic gastric cancer in Japan nivolumab and irinotecan as standard treatment of the third line.

The new drug is a combination of trifluridine, Tipiracil, a nucleoside metabolic inhibitor, and a thymidine phosphorylase inhibitor. This dose will benefit the patients who have gastric cancer and can no longer be treated with other therapies.

Lonsurf consists of a nucleoside analogue that is based on thymidine, and the trifluridine thyridine phosphorylase inhibitor Tipiracil. After taking in tumor cells trifluridine is incorporated into the DNA, interfering with DNA synthesis and inhibiting cell proliferation. In addition to the indication for metastatic gastric cancer Lonsurf is also indicated for the treatment of adult patients with metastatic colorectal cancer previously treated with fluoropyrimidine-based chemotherapy, oxaliplatin and irinotecan, an anti-cancer therapy. Biological VEGF, anti-EGFR treatment.

The research was conducted on 507 patients with unresectable metastatic adenocarcinoma in the stomach. The research included two different groups, the trifluridine / tipiracyl group and the placebo group.

David Cunningham, a consultant oncologist, says:

“We have nothing else we can offer those patients, and this study shows that we can extend life expectancy and improve disease control rates up to a very significant level.”

According to the researchers, this new treatment would meet the needs of patients.

How Lonsurf  Work?

Its dual mechanism of action is designed to maintain clinical activity and differs from conventional fluoropyrimidines. The trifluridine (FTD) is an antineoplastic nucleoside analog that is embedded directly into the DNA and therefore interferes with the function of DNA. The blood concentration of FTD is maintained by tipiracil (TPI), an inhibitor of the FTD thymidine phosphorylase degradation enzyme.

Dosage

The scientists recommended an oral dose of Lonsurf of about 35 mg / m2 / dose twice a day. The drug should be taken during the 28-day cycle from day 1 to day 5 and from day 8 to day 12.

In Japan, Taiho Pharmaceutical has been marketing Lonsurf for the treatment of advanced or recurrent advanced colorectal cancer. In the United States, Taiho Oncology, Inc., a US subsidiary of Taiho Pharmaceutical, began the pharmacological treatment of patients with mCRC previously treated with fluoropyrimidine-based chemotherapy as of 2015. Oxaliplatin and irinotecan, an anti-VEGF biological therapy and in wild-type RAS an anti-EGFR therapy. In 2015, Taiho Pharmaceutical and Servier entered into an exclusive licensing agreement for the joint development and marketing of LONSURF in Europe and other countries compared to the United States, Canada, Mexico and Asia. TTY Biopharm, a commercial partner of Taiho Pharmaceutical, launched LONSURF in July 2018 in parts of Asia outside of Japan in Taiwan. Jeil Pharmaceutical is preparing to commercialize the drug in South Korea.