Pfizer, Abbott Plan Parallel Filing for FDA Approval of NSCLC Drug Crizotinib, FISH Test
January 19, 2011
Pfizer, Abbott Plan Parallel Filing for FDA Approval of NSCLC Drug Crizotinib, FISH Test
The drug/diagnostic codevelopment partners are each planning to complete regulatory submissions with the FDA in the first half of this year for a pharmacogenomic NSCLC treatment targeting patients with the EML4-ALK-fusion oncogene.
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 - Focusing on Personalized Medicine, Pfizer Reports PGx Data for Several Oncologics at ASCO
June 9, 2010 / Pharmacogenomics Reporter - Abbott Seeks Approval in US, Japan for Dx to Pick Best Responders to Pfizer's Crizotinib
May 25, 2011 / Pharmacogenomics Reporter - CHMP Recommends Conditional Marketing Authorization for Pfizer's Leukemia Drug
January 23, 2013 / Pharmacogenomics Reporter - European Regulators Grant Conditional Approval for Pfizer's Xalkori; Abbott Begins Marketing ALK CDx
October 24, 2012 / Pharmacogenomics Reporter