Trends-in-MedicineLynne Peterson,
Senior Writer
Trends-in-Medicine has no financial connections with any pharmaceutical or medical device company. The information and opinions expressed have been compiled or arrived at from sources believed to be reliable and in good faith, but no liability is assumed for information contained in this newsletter.
Copyright© 2003
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American Society of Hematology (ASH)
Summary: Doctors are excited about the expected approval of Genentech’s Avastin, but they are less optimistic about the outlook for most other angiogenesis inhibitors. OPAL-1, a new test appears to be highly predictive of which pediatric ALL patients will respond to therapy and which won’t. AstraZeneca’s Exanta looks promising to prevent VTE after knee replacement surgery, and Bristol-Myers Squibb’s razaxaban looks promising for DVTs, but liver enzyme elevations need to be watched with Exanta. Medicare reimbursement changes are a hot button with oncologists and hematologists, and many are worried that they will be forced to stop doing infusions or retire early. There was promising new data on BiogenIdec’s Rituxan, Celgene’s Revimid, Genta’s Genasense, Johnson & Johnson’s Zarnestra, and Millennium’s Velcade.
FDA Cardiovascular and Renal Drugs Advisory Committee Meeting on CV Therapeutics’ Ranexa (Ranolazine) - Quick Pulse
Summary: The FDA’s Cardio-Renal advisory panel agreed with the FDA that CV Therapeutics’ Ranexa is approvable but not until another trial is completed, and then probably only with a restricted label for use in patients who cannot take other antianginal medications or whose angina is not controlled with maximum tolerated doses of available drugs. The panel was less concerned with QT prolongation than the FDA, but more concerned about syncope. This means Ranexa is unlikely to be approved for at least 12-24 months. In addition, the company still must address FDA concerns about testicular toxicity.
American Society of Nephrology
Summary: Shire has completed more than 80 studies attesting to the safety of Fosrenol (lanthanum), but a competitor, Genzyme, found liver and kidney accumulation in rats and is sending that data to the FDA, which could delay Fosrenol approval. When Fosrenol is approved, it is likely to significantly impact sales of Genzyme’s Renagel because it has a lower pill burden and the pills are chewable. The concern about PRCA with Johnson & Johnson’s Eprex has abated now that it is given only IV. The Phase II data on Roche’s pegylated erythropoietin, CERA, looked very good. Amgen/NPS’s calcimimetic, cinacalcet, is likely to be a big hit – provided it isn’t priced out of the market. Cinacalcet is likely to decrease use of vitamin D analogs but not phosphate binders. Cost will be a huge factor in the outlook for any new agent in nephrology.
American Heart Association
Summary: Among the positive trials reported at this meeting were: AstraZeneca's Exanta in SPORTIF-V, Pfizer's Lipitor in REVERSAL, and Otsuka Pharmaceutical’s Pletal (cilostazol) in CREST. Negative trials included Alexion's pexelixumab in PRIMO-CABG, Otsuka's tolvaptan in ACTIV, and Johnson & Johnson's ReoPro and Retevase in BRAVE. Mixed, incomplete or inconclusive data were presented about The Medicine Company's Angiomax in REPLACE-2 and Novartis’s Diovan in VALIANT. Other topics discussed at the meeting and discussed in this report include endothelin-1 antagonists, BNP, ICDs, and subacute thrombosis with drug-eluting stents.
North American Spine Society
Summary: Interest by patients and spine surgeons in artificial discs is extremely high. Usage is expected to take off dramatically when the first disc is approved, and this is attracting a plethora of companies to this space. Even Boston Scientific and Guidant reportedly are looking at entering this market. Spine surgeons continue to favor kyphoplasty over vertebroplasty, but growth in kyphoplasty procedures is expected to slow due to cost, reimbursement, rumors CMS will issue a CPT code, and improving results with vertebroplasty. Kyphoplasty is good medicine, but it’s bad from a business sense. The high cost of the first BMP, Medtronic’s InFuse, is limiting use, and excitement over BMPs in general appears to have waned a bit.
FDA Panel Recommends Appoval of Two New Cosmetic Fillers: Restylane and Hylaform - Quick Pulse
Summary: The FDA’s General and Plastic Surgery Devices Panel recommended on November 21, 2003, that the FDA approve two new cosmetic fillers – Medicis/Q-Med’s Restylane and Genzyme’s Hylaform (to be marketed by Inamed). Both clear gel products were found to be comparable, not superior, to Inamed’s Zyplast, which has been considered the gold standard of fillers for many years. Dermatologists and plastic surgeons have been anxious for a non-bovine fillers like Restylane and Hylaform, though neither contains lidocaine or another pain killer.
Endpoints For Ophthalmology Trials - Quick Pulse
Summary: The FDA has been holding a series of meetings to discuss appropriate endpoints for clinical trials for cancer drugs, and these will continue. Oncology is not the only division of the FDA that is wrestling with issues relating to endpoints. The issues may be more complex in oncology, but there are concerns in other fields, including ophthalmology. This Quick Pulse examines the issues relating to ophthalmic clinical trial endpoints.
FDA Colon Cancer Workshop
Summary: This was only the first step in an effort to revise acceptable endpoints in colorectal cancer trials, and no decisions were made. An industry rep made a plea for acceptance of time to progression (TTP) as an endpoint, saying it is objective, reliable, practical and cost saving. However, the FDA does not appear ready yet to accept TTP endpoints, which are still con-sidered difficult to interpret. The FDA also is not enthusiastic about non-inferiority survival trials in first-line, second-line or refractory settings because they don’t move the field ahead, and problems arise due to sloppiness, crossovers, lack of confirm-atory trials, etc. Single-arm studies are being allowed for approval before a randomized trial is completed, and that is unlikely to change in the near future. Bio-markers and quality of life will be useful endpoints eventually, but they are not ready for prime time yet.
Clinical Trial Designs and Endpoints: FDA Oncologic Drugs Advisory Committee (ODAC)
Summary: The ODAC panel reviewed the findings of an April 2003 meeting on lung cancer endpoints and spent a full day discussing issues the FDA wanted clarified. Much of the discussion focused on time-to-progression (TTP) as an endpoint, and the panel decided that progression free survival (PFS) is a better endpoint than TTP. A panel felt PFS could support both regular and accelerated drug approval in metastatic NSCLC but not inoperable NSCLC. The panel also recommended that disease free survival (DFS) be permitted as an endpoint for regular drug approval.
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