EGFR has emerged as a primary area of interest in cancer research, with biopharmaceuticals like Imclone's Erbitux and Amgen's Vectibix targeting the protein, but its multiple isoforms have made it difficult to predict these drugs' effectiveness, said Yale professor Nita Maihle.
Pfizer completed submission of its NDA for the ALK-inhibiting non-small cell lung cancer drug crizotinib, and was granted a priority review from the FDA. Meantime, Abbott Molecular plans to submit "shortly" a premarket approval application for a commercial companion diagnostic that will pick out best responders to crizotinib.
"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.
Transgene plans to use the tests from Ventana and Beckman Coulter to analyze which subpopulations of patients with advanced NSCLC will likely respond best to the MVA-MUC1-IL2 immunotherapeutic in combination with first-line therapy.
Insight is developing the tests using TaqMan probes on Life Technologies' ABI 7500 Fast Dx real-time PCR system to help physicians monitor cancer patients for mutations and upregulation in the ALK gene in order to make more effective treatment decisions.