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The small molecule treatment is indicated as a first-line maintenance treatment for individuals with advanced ovarian cancer regardless of their BRCA mutation status, who have responded to first-line platinum-based chemotherapy. ” The EC based its approval the Phase III ATHENA-MONO study results.
In fact, off-label drug uses can become widely entrenched in clinical practice and become predominant treatments for a given clinical condition. In a study published in JAMA Internal Medicine , off-label use lacking strong scientific evidence had a higher adverse drug event rate compared with on-label use.
The Ministry of Health, Labour and Welfare (MHLW) in Japan has cleared Ezharmia (valemetostat tosylate) based on the results of an open-label phase 2 trial which revealed a 48% overall response rate with the drug in previously-treated ATL patients.
Nonetheless, there are also circumstances where we have to read up the clinical practice guidelines or clinical journals to justify the dosing of a particular drug, especially those off-label indications. Hence, with a dosing of 1 mg, an ampoule of 3mg granisetron can be used for 3 patients, making it very cost effective.
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