GLG News by Nexavar Prescribers for RCC: Oncologists (US)

The comprehensive clinical program will supplement the significant body of clinical data existing for ERBITUX in colorectal and head and neck cancers by exploring the use of ERBITUX in additional tumor types including brain, breast, bladder, gastric, lung, pancreas and prostate

The coverage restrictions placed on the FDA-approved indication have no scientific basis and are incompatible with good clinical practice," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Global Research and Development at Amgen. "We are concerned that inappropriately limiting coverage...

My understading id medicare need to cover all FDA indicated drugs. Here CMS violating FDA indication for Aranesp and procrit

Decrease use by 20-25% use of ESA. This may lead discounting and higher rebate from both amgen and orto-biotech to sustain market share. Since most of amgen contract with aranesp and neulasta use. It may effect use of neulasta. Next 6 month CMS may restrict use of Neulasta and neupogen for neutropenia...

no doubt that Velcade has shown superior results . it deserved to be used as induciton regimen ( unles patient has pre-existing neuropathy)  for transplant. velcade is  more efficacious ,less toxic and more easier to give than VAD regimen.

Xcytrin (motexafin gadolinium) is a rationally designed compound that concentrates selectively in cancer cells, inducing redox stress and triggering apoptosis (cell suicide). Xcytrin has been shown to be synergistic with radiation and in the pivotal phase III SMART trial was shown to improve the...

The primary end point of the phase III trial "Imatinib Mesylate (Gleevec) in Treating Patients with Primary GIST that has been Completely Removed by Surgery" was recurrence free survival with the secondary endpoints of overall survival, efficacy, and safety. The study was closed early with the announcement...

Nexavar continues to expand its place in the oncology arena.Nexavar is approved for renal cell ca and I suspect hepatocellular approval is not far behind.

1. Herceptin is one of the favorite drugs used by oncologists2. Optimal schedule and length is not clear3. Role of additional testing is not established4. Competition is around the corner

Implications: 1. Drug will be delayed further2. Abraxane and Epothilone B will be approved. 3. If management understood that approach of early 80s does not work now, the drug would be available on market years ago.