ROCKVILLE, MdThe FDA approved 160 medications and
medical devices last year, including a number of oncology products. Among the
most important cancer medications approved for the first time or for a new
Trisenox (arsenic trioxide) was approved for the
treatment of acute pro-myelocytic leukemia (APL) in patients who failed all-trans-retinoic acid and anthracycline-based chemotherapy, or who relapsed
after such medication.
Mylotarg (gemtuzumab ozogamicin), a monoclonal
antibody, targets the CD33 antigen that appears on about 85% of acute myeloid
leukemia (AML) cells. It won approval for use in AML patents age 60 and older
who have relapsed for the first time and who are not candidates for standard
Nolvadex (tamoxifen citrate) was approved for a new
indication to reduce the risk of invasive breast cancer for women with
preinvasive cancer of the milk ducts.
Pacis (BCG Live) was approved for treating cancer in
situ in the absence of associated invasive cancer of the bladder.
Actimmune (interferon gamma-1b) received approval for
delaying time to disease progression in malignant osteopetrosis.
Camptosar (irinotecan) gained a new indication as
first-line therapy in combination with fluorouracil and leucovorin for
metastatic colorectal cancer.
FDA regulators also approved several medical devices for use in
The Optical Biopsy System, a laser procedure operated
through an endoscope, enables physicians to distinguish small, harmless growths
in the colon from precancerous polyps. It can evaluate growths less than 1 cm
The Senographe 2000D, the first digital mammography
system to be approved by the FDA, produces images on a solid-state receptor.
"Unlike radiographic film, digital images can be electronically stored and
transferred, so they can be evaluated by a specialist at a remote
location," the agency noted.
The FocalSeal-L Surgical Sealant was approved for
closing air leaks in the lungs of patients following the removal of cancerous