In the study, out of three patients with ALK gene rearrangements, two responded partially to Infinity's investigational drug IPI-504, and one experienced prolonged stable disease while on the treatment for 7.2 months and had a 24 percent reduction in tumor size.
NICE's recommendation for NHS to pay for AstraZeneca's non-small cell lung cancer drug Iressa in EGFR mutation-positive patients marks the second personalized medicine product to be funded in the UK after Herceptin was approved in 2002 for HER2-overexpressing breast cancer patients.
In addition to several PGx studies presented at the conference, the International Association for the Study of Lung Cancer and the European Thoracic Oncology Platform's European EGFR Workshop Group proposed recommendations on EGFR mutation testing in NSCLC when patients are treated with AstraZeneca's Iressa.
Ahead of a cost-effectiveness appraisal by UK's NICE, AstraZeneca is paying for EGFR mutation testing for non-small cell lung cancer patients to determine if they will benefit from treatment with Iressa. The genetic testing program is part of a patient access scheme the company has agreed to with the National Health Service to provide more granularity about the cost and value of the treatment.
Scientists from Case Western Reserve University and Fluidigm have demonstrated how the nanofluidic digital PCR platform can detect and quantify EGFR mutations at the single-molecule level from lung tumors, including FFPE samples.
Clarient Insight Dx Pulmotype is a five-antibody immunohistochemistry test that the company said can be used to aid in the histological distinction between adenocarcinoma and squamous cell carcinoma in NSCLC tumor specimens.
Clarient plans to commercialize Applied Genomics' five-antibody immunohistochemistry test for non-small cell lung cancer, called Pulmotype, within its network of pathologists by the first quarter of 2010.
According to an editorial in the New England Journal of Medicine, two new studies suggest "that EGFR mutations represent favorable prognostic markers of survival and are predictive of tumor shrinkage, but the evidence that they can predict a differential effect of tyrosine kinase inhibitors on survival is incomplete."
"If approved by the FDA, the DxS TheraScreen: K-RAS Mutation Kit would become a companion diagnostic for use with Erbitux in metastatic colorectal cancer to determine which patients have wild-type KRAS status in the US," DxS said this week.