SFJ Pharmaceuticals and Pfizer to co-develop dacomitinib as treatment for non-small cell lung cancer
Phase 3 Trial to be Conducted Across Sites in Asia and Europe
The SFJ Pharmaceuticals Group (SFJ), announced that it has entered into a collaborative development agreement with Pfizer Inc. to conduct a Phase 3 clinical trial of Pfizer’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 agreement, 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.
This is the second collaborative agreement between SFJ and Pfizer. SFJ previously entered into an agreement with Pfizer to conduct a Phase 3 trial in Asia of Pfizer’s Inlyta® (axitinib) for the adjuvant treatment of patients at high risk of recurrent renal cell carcinoma following nephrectomy.
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