Top of the morning to you. And a fine one it is. The sun is shining brightly and there are no clouds hovering over the Pharmalot corporate campus, where we are hustling those short people off to the local schoolhouses. Meanwhile, we are brewing that famous cup of stimulation and preparing for another busy day. And there is much to do. So here is that regular menu of tidbits to get you going. Hope you have a great day and let us know if you hear anything interesting...
Arena Is A Hot Stock As FDA Review Of Diet Pill Begins (Associated Press)
Cipla Breached Patent Rights By Cutting Nexavar Price: Bayer (Hindu Business Line)
FDA Panel Recommends Pfizer Rheumatoid Arthritis Pill (Bloomberg News)
FDA May Speed Approval Of Breakthrough Drugs (Reuters)
UK's NICE Backs Roche's Tarceva For Lung Cancer (Reuters)
As More Generics Loom, Pfizer Gives Up Lipitor Marketing (Wall Street Journal)
J&J Opens Doxil Rationing To New Patients (Dow Jones)
Glaxo: We Complied With Indian Rules For Drug Approval (Wall Street Journal)
Novartis To Probe Indial Drug Approval Allegations (Reuters)
Congress May Allow FSA Funds For OTC Meds Without An Rx (Amed News)
Lethal Injection Drug Held By Nebraska Is Recalled (Associated Press)
USDA Asks MRI To Rework Enclosures After Animal Death (Outsourcing Pharma)
J&J And Bayer Seek Expanded Use For Xarelto (Associated Press)
Pfizer Distribution Policy Criticized By Australian Wholesaler (Sydney Morning Herald)
EDITOR'S NOTE: Please check this post for updates
3 Comments
Despite high response rates in mutation positive patients, approximately 30-40% of patients with the appropriate biomarker do not respond. In addition, patients who do not carry EGFR mutations can nonetheless respond to these classes of drugs (Iressa and Tarceva). This reflects the complexity, redundancy and promiscuity of signal pathways, such that, pathway cross-talk has the capacity to salvage cancer cells from the lethal effects of these inhibitors.
The USFDA approved indication for Tarceva did not limit prescribing specifically to EGFR positive patients. In the registration trial, only one third of the patients were tested for EGFR and determining response based on EGFR was not a major endpoint of the study. Testing for the EGFR mutation "may" be able to tell you whether or not your cancer cells are "potentially" susceptible to this mechanism of attack. It cannot tell you if Tarceva will work for your "individual" cancer cells, or if Iressa would be better.
But you wouldn't know this using a genotype-driven analysis (indirect approach to drug selection). Rather than only give Tarceva to all patients with EGFR+ NSCLC, it could be given selectively to patients with all types of cancer, if it otherwise indicated and if a phenotype-driven analysis is positive for it. It could be vastly more beneficial to measure the net effect of all processes (systems) instead of just individual molecular targets.
Genetic variations alone do not determine response to targeted therapy. Those patients who test negative for EGFR are left out in the cold, to the same guesswork as conventional therapy. Tarceva (even Iressa) could be given selectively to patients with EGFR negative NSCLC. It is a challenge to identify which patients targeted treatments like Tarceva will be effective. Patients across a broad range of clinical characteristics could benefit. Being EGFR negative is no reason not to be given this drug!