Pfizer links with SFJ Pharma for dacomitinib trial; settles with Mylan

SFJ Pharmaceuticals Group, a global drug development group of companies which provides a unique co-development partnering model (SFJ), has entered into a collaborative ement with Pfizer (NSE: PFE) to conduct a Phase III clinical trial of the pharma behemoth’s investigational pan-HER (pan-human epidermal growth factor receptor) inhibitor, dacomitinib (PF-00299804).

The trial, which will be conducted across multiple sites in Asia and Europe, will evaluate dacomitinib as a first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of epidermal growth factor receptor (EGFR).

Under the terms of the accord, SFJ will provide the funding and clinical development supervision to generate the clinical data necessary to support a registration dossier on dacomitinib for marketing authorization by regulatory authorities for the indication: First-line treatment of patients with locally advanced or metastatic NSCLC with EGFR activating mutations. If approved for this indication, SFJ will be eligible to receive milestone payments and earn-out payments.