On August 26th 2011, Pfizer announced approval by the FDA of XALKORI (crizotinib) – an ALK-specific kinase inhibitor ‑ for the treatment of patients with ALK-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC). XALKORI was developed and approved in parallel with a molecular companion diagnostic, developed by Abbot Molecular, aimed at detecting the rearrangement of the ALK gene on the 2p23 chromosome by Fluorescent In Situ Hybridization (FISH).
The parallel approval of this new drug with the companion diagnostic ALK FISH marks the first example of personalized therapy for lung cancer and reinforces the growing trend of personalized medicine in oncology. Indeed, earlier this month, the FDA approved Zelboraf (vemurafenib) and companion diagnostic for BRAF-mutation positive metastatic melanoma (See: A biomarker finds its drug), adding to the list of cancer treatments that depend on companion diagnostics (See: Personalized cancer medicine review).
Thierry
Sornasse for Integrated Biomarker Strategy
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