Friday, July 8, 2011
Thursday, July 7, 2011
FDA Okays Fentanyl Nasal Spray for Ca Pain - in Public Health & Policy, FDA General from MedPage Today
Medical News: FDA Okays Nasal Spray for Ca Pain - in Public Health & Policy, FDA General from MedPage Today
By Cole Petrochko, Associate Staff Writer, MedPage TodayPublished:
July 02, 2011 WASHINGTO -- The FDA has approved a nasal spray formulation of the drug fentanyl (Lazanda) to manage breakthrough pain in cancer patients ages 18 and older who are already using opioid therapy. The drug comes in 100 mcg- and 400 mcg-spray doses.
Drug efficacy was established in a double-blind study that found fentanyl nasal spray outperformed placebo at the primary endpoint of sum of pain intensity difference at 30 minutes.
The nasal spray formulation is not equivalent to other fentanyl products for breakthrough pain on a microgram-per-microgram basis. Healthcare professionals prescribing Lazanda should not convert from other fentanyl products. A dosage conversion guide is not available at this time.
Everolimus Trial Stopped for Benefit in Breast Cancer - in Oncology/Hematology, Breast Cancer from MedPage Today
Medical News: Everolimus Trial Stopped for Benefit in Breast Cancer - in Oncology/Hematology, Breast Cancer from MedPage Today
Excerpt:
"A phase III trial of everolimus (Afinitor) in locally advanced or metastatic breast cancer has been halted after an interim analysis indicated that the study's primary endpoint -- a significant difference in progression-free survival relative to a control therapy after six weeks -- was met, the drug's manufacturer said.
According to Novartis, the combination of everolimus and exemestane (Aromasin) was more effective than the latter drug and placebo in preventing tumor growth in women with estrogen receptor-positive, HER2-negative breast cancer that did not respond to other aromatase inhibitors.
The international trial, BOLERO-2, was testing everolimus at 10 mg/day orally plus 25 mg/day of oral exemestane. It included more than 700 patients randomized 2:1 to the combination versus the control regimen.
Novartis did not indicate the degree of improvement in progression-free survival with the combination. It promised that full results would be presented at "an upcoming medical conference" and that it would file marketing applications worldwide by the end of this year."
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