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GSK files NDA in the US

GlaxoSmithKline has submitted a new drug application in the US for an investigational medicine that could help people suffering from the side effects of chemotherapy
GlaxoSmithKline (GSK) has submitted a new drug application (NDA) in the US for an investigational medicine that could help people suffering from the side effects of chemotherapy.

Casopitant has been developed to treat chemotherapy-induced nausea and vomiting (CINV) and GSK has filed an NDA under the brand names Rezonic/Zunrisa with the US Food and Drug Administration (FDA). The drug performed well during trials, with results showing that it significantly reduced the number of patients who experienced CINV.

According to GSK, the impact of CINV on a patient's quality of life can lead to some people delaying or refusing to undergo further chemotherapy. The company said that 40 to 50 per cent of patients still succumb to breakthrough CINV despite being on standard anti emetic treatments.

"There are still patients who still suffer from the unfortunate side effects of CINV in spite of standard dual therapy," said lead investigator, Dr Steven Grunberg from the Vermont Cancer Centre at the University of Vermont and Fletcher Allen Health Care in Burlington Vermont.

"I consider these results for casopitant as a very exciting step toward a convenient and effective oral option to provide much needed relief."

Patients who have undergone highly emetogenic chemotherapy (HEC) have a 90 per cent chance of experiencing CINV, which can last for up to five days. That figure is between 30 and 90 per cent for people on a course of moderately emetogenic chemotherapy (MEC).

Phase III trial of the new drug, involving HEC patients, showed a patient response rate of 86 per cent for single oral doses of the medication. The response rate in trials of patients undergoing (MEC) was 76 per cent for single or three-daily doses of the drug.

Specific data about casopitant collected during studies was revealed by the company at the 44th Annual Meeting of the American Society of Oncology (ASCO) in Chicago.

Dr Paolo Paoletti, senior-vice president of oncology research at GSK, said: "Our goal is not only to eradicate cancer, but also to help patients cope with their cancer and the often unwanted consequences of treatment, such as CINV, that many patients face."

30th May 2008

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