December 2006 Issues

European Organization for Research and Treatment of Cancer (EORTC)

Summary: There wasn’t a lot of breaking news at the EORTC meeting, but there was an interesting finding in ALL that could have implications for development of new therapies in that cancer. ♦ Combinations of targeted therapies and angiogenesis inhibitors got a push, but not without some controversy. ♦ The aurora kinase inhibitors getting attention were Millennium’s MLN- 8054, Nerviano’s PHA-739358, and SuperGen’s MP-529. ♦ Despite the challenges, telomerase remains an attractive target for cancer therapy. ♦ mTOR inhibitors are looking promising in cancer as well as immunosuppression, but there were reports of pneumonitis with Novartis’s everolimus. ♦ Praecis Pharmaceuticals’ PPI-2458, a MetAP-2 inhibitor, and Hana Biosciences’ Talvesta (talotrexin) were particularly interesting. ♦ A variety of other drugs and approaches were featured, including: MEK inhibitors, oral taxanes, TKIs, anti-ROS, a non-polyglutamable antifolate, AKT inhibitors, heat shock protein (HSP) inhibitors, and kinesin spindle protein (KSP) inhibitors.  

FDA’S Circulatory System Devices Advisory Committee Meeting on Drug-Eluting Stents

Summary: The FDA advisory panel was mostly an opportunity for doctors on all sides of the drug-eluting stent safety debate to let off steam. FDA officials indicated that there will not be a black box on current DES, and the ARC definitions of stent thrombosis will be the Agency’s preferred method. The panel:

♦ Agreed there is an increased risk of stent thrombosis with DES vs. BMS.

♦ Recommended 12 months of dual antiplatelet therapy for most DES patients.

♦ Urged trials be longer and larger in the future and that registries should have a control arm.

♦ Found no significant difference in risk between Johnson & Johnson’s Cypher and Boston Scientific’s Taxus.

♦ Did not appear to recommend anything that would delay approvals of new DES in the near pipeline.  

American Society of Nephrology's Renal Week

Summary: Use of Amgen’s Epogen and Aranesp is likely to decrease due to the CHOIR trial, which found that hemoglobin >13 increased the risk of heart attack, death, and stroke. Doctors plan to more closely target Hgb 11-12, CMS is expected to reinstitute a hemoglobin ceiling for reimbursement, and the KDOQI anemia guidelines may change. ♦ Nephrologists were very excited about Roche’s once- or twice-monthly Mircera, which increases hemoglobin more gradually and perhaps makes it easier for doctors to manage hemoglobin levels. ♦ Advanced Magnetics’ ferumoxytol, an IV iron in development that requires fewer injections than current products, appears efficacious, but the safety data were not fully presented, and nephrologists expressed little excitement over it, so some questions remain. ♦ AffyMax’s hematide continues to look promising, not only as a new, nonrefrigerated, and perhaps less expensive ESA, but also as a treatment for PRCA. ♦ Phase II data on Keryx BioPharmaceuticals’ new phosphate binder looked promising. Nephrologists generally were unaware of it but interested in a new product.

Preview of the FDA Advisory Committee Meeting on Drug-Eluting Stents -- Quick Pulse

Summary: Dr. Daniel Schultz, Director of the FDA’s Center for Devices and Radiologic Health (CDRH), held a teleconference with reporters two days before the FDA’s Circulatory System Devices Advisory Committee meeting December 7-8, 2006 , on the safety of drug-eluting stents (DES).

Medicare Coverage Advisory Committee Meeting on Spinal Fusion for the Treatment of Low Back Pain Secondary to Lumbar Degenerative Disc Disease -- Quick Pulse

Summary: The spine industry appears to have dodged a big federal bullet. The Centers for Medicaid and Medicare (CMS) convened a Medicare Coverage Advisory Committee (MCAC) to review the efficacy and safety of spinal fusion, raising the concern that the government might cut or eliminate payment for those procedures, but a CMS official opened the meeting with a strong statement that this was not the purpose of the session. At the end of the day, the panel members voted that the evidence on both safety and efficacy in elderly patients is sparse and called for further study, but there was no suggestion that the procedures should be restricted. The field will now have to wait to see what CMS decides the further study or studies need to be – a registry or a randomized clinical trial (RCT) – but there is little doubt further studies will be required.