March 2006 Issues

ASCO Prostate Cancer Symposium

Summary: Deferring treatment of some prostate cancer is feasible but is still not acceptable to most doctors and patients. ♦ Proton beam radiation devices may be the technology to watch for the future. ♦ PSA doubling time (PSADT) is starting to replace PSA measurement for detecting prostate cancer and predicting its aggressiveness, and Gen- Probe’s Aptima PCA3 assay looks promising, but higher sensitivity and specificity are needed before it gets widespread adoption. ♦ Chemotherapy should be used earlier, more aggressively, and as part of a multimodal treatment approach. Of particular interest were Genentech’s Avastin and epothilones, especially Bristol-Myers Squibb’s ixabepilone and Novartis’s ZK-EPO ♦ Doctors were cautiously optimistic that Abbott’s Xinlay will eventually get FDA approval, for delaying formation of bone metastases, not therapy of prostate cancer. ♦ Other agents worth watching include: Celgene’s Revlimid, Novacea’s DN-101 (high dose calcitriol), and OncoGenex Technologies’ OGX-011 and OGX-427.

FDA-Approved ADHD Drugs Found Beneficial And Safe, But Safety Of A New ADHD Drug Questioned

Summary: Two FDA advisory committees met on ADHD drugs in the same week. One determined that the cardiovascular and psychiatric side effects of ADHD drugs are a class effect and do not warrant a black box warning, with the exception of a suicidality warning on Lilly’s Strattera. The panel advised the FDA that the labels should all be the same, and a MedGuide should be prepared by the FDA to further inform parents about potential risks and warning signs with the drugs. The other panel determined that Cephalon’s Sparlon (modafinil) is effective in ADHD, but they were not convinced it has been shown to be safe. The panel recommended the company be required to conduct a large safety trial before approval. .

Eyecare Update #2

Summary: To check on trends in the eyecare field, 60 optometrists from seven East Coast and Midwest states were interviewed at the Dade County Optometric Association's Miami Nice Education Symposium in Miami FL on March 4 and 5, 2006. They offered opinions and outlooks on silicone hydrogel contact lenses, contact lens solutions, dry eye, refractive surgery, multifocal IOLs for cataract and refractive patients, and more.

FDA Panel Recommends Tysabri Return to the Market for Multiple Sclerosis

Summary: An FDA advisory committee voted unanimously that Tysabri is effective and should be returned to the market as monotherapy but only for adults with relapsing MS who are not taking any immunosuppressant or immunomodulator. ♦ They did not recommend that Tysabri be restricted by disease severity or prior treatment experience, and they were split on whether patients should be allowed to have Tysabri first-line, so that decision will be made by the FDA. ♦ The panel accepted the company’s proposed mandatory risk management program – a registry of all Tysabri patients – with the additional requirements that patient checklists be reported to the company monthly and distribution be halted to patients, doctors, and infusion centers that are non-compliant. ♦ However, the panel agreed there is still a risk of PML -- and cases of PML are likely when patients start taking the drug again.

FDA Softens Warnings About the Safety of Birth Control Patches -- Quick Pulse

Summary: The FDA is warning women not to overreact to reports that using Johnson & Johnson’s Ortho Evra (norelgestromin/ethinyl estradiol transdermal system) birth control patch may double the risk of developing a blood clot to taking an oral contraceptive. ♦ In mid-February 2006, Dr. Daniel Shames, director of the FDA’s Division of Reproductive and Urologic Drug Products, Center for Drug Evaluation and Research (CDER), told reporters that the FDA has no plans for any specific regulatory action at this time.

Anti-Infective Drugs Advisory Committee Recommends Label Expansion for Cubist Pharmaceuticals' Cubicin (Daptomycin) -- Quick Pulse

Summary: Cubist filed an sNDA for Cubicin in September 2005, seeking a label expansion for Cubicin to include community-associated methicillin-resistant S. aureus (CAMRSA). ♦ The FDA granted priority review in November 2005, and the Agency’s action date is March 29, 2006. ♦ With a unanimous advisory committee vote in favor of approval, FDA approval looks almost certain.