Fast-Tracking Oncology Drugs Questioned?
Cancer drugs rushed to the market via the FDA's accelerated approval process often languish in confirmatory trials, agency researchers say.
Out of 47 indications granted fast-track status, benefits have not yet been confirmed in 21, mostly because trials are ongoing, according to John R. Johnson, MD, of the FDA's oncology drugs office, and colleagues.
"Lack of due diligence in conducting confirmatory trials is a serious concern that has threatened the continuation of the accelerated approval process," they wrote online in the Journal of the National Cancer Institute.
They noted that the Food, Drug, and Cosmetic Act of 2007 gives the FDA authority to levy penalties of up to $10 million on pharmaceutical companies for not completing trials for fast-tracked drugs quickly enough.
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DX: 12-20-05 - Stage IIIA, Her2/Neu, 3+++,Er & Pr weakly positive, 5 of 16 pos nodes.
Rt. MRM on 1-3-06 -- No Rads due to compromised lungs.
Chemo started 2-7-06 -- TCH - - Finished 6-12-06
Finished yr of wkly herceptin 3-19-07
3-15-07 Lt side prophylactic simple mastectomy. -- Ooph 4-05-07
9-21-09 PET/CT "Recurrence" to Rt. axllia, Rt. femur, ilium. Possible Sacrum & liver? Now stage IV.
9-28-09 Loading dose of Herceptin & started Zometa
9-29-09 Power Port Placement
10-24-09 Mass 6.4 x 4.7 cm on Rt. femur head.
11-19-09 RT. Femur surgery - Rod placed
12-7-09 Navelbine added to Herceptin/Zometa.
3-23-10 Ten days of rads to RT femur. Completed.
4-05-10 Quit Navelbine--Herceptin/Zometa alone.
5-4-10 Appt. with Dr. Slamon to see what is next? Waiting on FISH results from femur biopsy.
Results to FISH was unsuccessful--this happens less then 2% of the time.
7-7-10 Recurrence to RT axilla again. Back to UCLA for options.