In a new study, tamoxifen citrate (Nolvadex drags, AstraZeneca), best known as a treatment for breast cancer, dramatically reduced symptoms of the manic phase of bipolar disorder more quickly than many standard medications for the mental illness. By the end of the study, 63% of the patients taking tamoxifen had reduced manic symptoms, compared with only 13% of those taking a placebo. Patients taking tamoxifen responded by the fifth day.
The FDA has approved oral topotecan (Hycamtin capsules) for patients with relapsed small cell lung cancer (SCLC).
This agent is indicated for patients who have had a complete or partial response to first-line chemotherapy and who are at least 45 days from the end of that treatment.
Millennium Pharmaceuticals has announced the FDA’s approval of bortezomib (Velcade), without dose adjustments, for use in patients with impaired kidney function, including patients who need dialysis. Impaired kidney function is a common complication related to multiple myeloma.
Docetaxel (Taxotere Injection Concentrate, Sanofi-Aventis), combined with cisplatin and 5-fluorouracil (5-FU), is now approved for induction therapy of locally advanced squamous cell carcinoma of the head and neck before patients undergo chemoradiotherapy and surgery.
Patients with advanced breast cancer drug that has not responded to other anti-cancer drugs may soon have a new treatment option. Ixabepilone (Ixempra, Bristol-Myers Squibb) has been approved for use in combination with another cancer agent, capecitabine (generic Xeloda, Roche), in patients who no longer benefit from treatment with an anthracycline (such as doxorubicin [Adriamycin, Bedford]) and a taxane (such as paclitaxel [Taxol, Bristol-Myers Squibb] or docetaxel [Taxotere, Sanofi-Aventis]). Ixabepilone is also approved for use alone in patients who no longer benefit from an anthracycline, a taxane, and capecitabine.
Bristol-Myers Squibb, Eli Lilly, and Amgen are now able to state that colon cancer patients with a mutation to the KRAS gene do not respond to two of their drugs. The FDA has approved revised labeling for cetuximab (Erbitux, Bristol-Myers Squibb/ImClone) and panitumumab (Vectibix, Eli Lilly and Amgen), which is in the same drug class. Merck KGaA markets Erbitux outside the U.S.
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The FDA is requiring stronger warnings in the prescribing information for tumor necrosis factor (TNF) blockers. An updated boxed warning highlights the increased risk of cancer drugs in children and adolescents who receive these drugs to treat juvenile rheumatoid arthritis, inflammatory bowel disorder, Crohn’s disease, and other inflammatory disorders.
