Abbott Seeks Approval in US, Japan for Dx to Pick Best Responders to Pfizer's Crizotinib
May 25, 2011
Abbott Seeks Approval in US, Japan for Dx to Pick Best Responders to Pfizer's Crizotinib
Shortly after Pfizer's regulatory filings for the NSCLC ALK-inhibitor crizotinib in these two countries, Abbott submitted its premarket approval application with US and Japanese regulatory authorities for a FISH-based companion diagnostic test.
Full-text access for premium subscribers only.
Existing premium subscribers login here.
New to GenomeWeb? Register here quickly.
New to GenomeWeb? Register here quickly.
Related Stories
- Pfizer Submits Crizotinib NDA with FDA; Abbott to File Companion Dx Approval Application Soon
May 18, 2011 / Pharmacogenomics Reporter - Pfizer, Abbott Plan Parallel Filing for FDA Approval of NSCLC Drug Crizotinib, FISH Test
January 19, 2011 / Pharmacogenomics Reporter - Focusing on Personalized Medicine, Pfizer Reports PGx Data for Several Oncologics at ASCO
June 9, 2010 / Pharmacogenomics Reporter - European Regulators Grant Conditional Approval for Pfizer's Xalkori; Abbott Begins Marketing ALK CDx
October 24, 2012 / Pharmacogenomics Reporter - Case Study Suggests FISH Test May Miss Some Patients Who Could Benefit from Crizotinib
September 12, 2012 / Pharmacogenomics Reporter