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| Biotech Tracker:
Thalomid: What’s in a Label? |
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February
23rd 2004. Celgene
(NASDAQ: CELG) announced that the FDA has accepted for review its
supplemental NDA for Thalomid (thalidomide) for the treatment of
multiple myeloma. Thalidomide, infamous because of the severe birth
defects it caused when given to pregnant women, has a wide variety
of therapeutic uses. Since it is currently approved in the U.S. for
the treatment of a specific complication of leprosy, thalidomide can
be, and has been, used off-label in cancer. In fact, it is
prescribed far more often for cancer than for leprosy. However,
Celgene cannot promote use for cancer to doctors.
Thalomid’s
adverse effect profile continues to be reassuring, given that
physicians know to avoid using thalidomide during pregnancy. In
spite of delays in gaining approval for the treatment of multiple
myeloma, we expect that Thalomid will become an important part of
the management of several indications. In addition to multiple
myeloma, Thalomid is being tested in late-stage trials relating to
non-specific immune disorders, apthous ulcers, and AIDS wasting
syndrome. Thalomid is in mid- and late-stage programs in HIV-related
diarrhea, AIDS-related Kaposi sarcoma, leukemia, and various solid
tumors. Thalomid is currently used off-label in Crohn disease, and
has generated encouraging mid-phase data in the management of
Waldenström macroglobulinemia, myelodysplastic syndrome, metastatic
melanoma, and inflammatory bowel disease. The jury is still out on
Thalomid’s ability to treat conditions such as refractory
pediatric malignancies and metastatic renal (kidney) cell carcinoma.
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