Date: 2011-08-16
Type of information: R&D agreement
Compound: companion molecular diagnostic test for dacomitinib
Company: Qiagen (Germany) Pfizer (USA - NY)
Therapeutic area: Diagnostic - Cancer - Oncology
Type agreement: research - R&D
Action mechanism: Qiagen’s proposed companion diagnostic will be based on its proprietary KRAS assay technology, which reliably detects mutations of the KRAS gene that are frequently found in human cancers.
Disease: non small cell lung cancer
Details:
- • On August 16, 2011, Qiagen has entered into a partnership with Pfizer for the development of a companion molecular diagnostic test for use with an investigational Pfizer compound, dacomitinib (PF-00299804), in global clinical development for treatment of non-small cell lung cancer (NSCLC). Dacomitinib is an oral inhibitor of HER-1 (EGFR), HER-2 and HER-4 tyrosine kinases. The HER (human epidermal growth factor receptor) signaling pathway plays a role in the complex process of cell growth and metastasis, making it a target for anti-cancer drugs. Qiagen recently submitted the application for Premarket Approval (PMA) for KRAS companion diagnostics to the FDA for use with two other, separate drugs targeting metastatic colorectal cancers. The Pfizer drug companion diagnostic test is being specifically developed for use in lung cancer tissue. It uses the same core assay component as the therascreen KRAS RGQ kit for colorectal cancers but varies in the workflow to allow for lung tissue-specific sample technology in a fully automated workflow. The global partnership covers clinical trials and submissions for a PMA application in the United States and the CE mark in Europe, as well as applicable regulatory approvals in other regions. Following clinical development of the KRAS companion diagnostic for NSCLC, QIAGEN expects to submit a premarket approval application supplement (PMAS) to FDA for full automation of the workflow to allow pathologists easy access and processing of lung tissue samples.
Financial terms: Financial terms of the agreement were not disclosed.
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