The European Commission will review CHMP's recommendation and is slated to issue a final decision regarding marketing authorization later this year.
The firm is developing a biomarker panel to detect mutations in mesenchymal cells, with the goal of guiding drug treatment and improving earlier patient intervention.
The diagnostic can now be used to identify patients with head and neck squamous cell carcinoma who may benefit from first-line treatment with Keytruda.
Starting with a head and neck cancer patient who showed an impressive response to pembrolizumab, researchers profiled gene fusion neoantigens in several tumor types.
During the meeting, researchers presented studies on combination immunotherapies and the efficacy of giving molecularly-informed treatments earlier in the disease continuum.
With sequence data for more than 118,000 tumors profiled at Foundation Medicine, investigators tracked PDL1 amplification prevalence and possible treatment implications.
The company is developing a companion diagnostic to identify head and neck cancer patients most likely to benefit from Erbitux.