"With genomics, and pharmacogenomics, and all the other aspects of the cancers, we have to think of a different way than the randomized trial," said Patrick Loehrer, interim director of Indiana University's cancer center and a member of FDA's Oncology Drugs Advisory Committee.
Although the decision to withdraw its accelerated approval NDA doesn't preclude the company from filing an entirely new NDA for Iressa in NSCLC patients with EGFR mutations, as it has done in several European countries, AstraZeneca has decided not to try to relaunch Iressa with a PGx strategy in the US.
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.