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GEN News Highlights : Sep 7, 2012

Pivotal Trial Support Provided for Lung Cancer Drug

SFJ Pharmaceuticals is to provide funding and supervise an international Phase III clinical trial evaluating Pfizer’s pan-Her inhibitor dacomitinib (PF-00299804) as first-line therapy for locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutations. The trial will be carried out at multiple sites in Asia and Europe, and is designed to generate clinical data necessary to support a registration dossier for dacomitinib for regulatory submission. If the drug is subsequently approved SFJ will receive milestone and earn-out payments.

The deal is the second between the firms. SFJ has previously inked an agreement with Pfizer to carry out a Phase III trial in Asia evaluating the latter’s Inlyta® (axitinib) for the adjuvant treatment of patients at high risk of recurrent renal cell carcinoma following nephrectomy.

Dacomitinib is an oral, once-daily small molecule inhibitor of Her-1, Her-2, and Her-4 tyrosine kinases. Pfizer’s clinical development program includes two global Phase III trials evaluating the drug as second-line and refractory treatment for NSCLC.