Letrozole Should Not Replace Tamoxifen As Standard Comparator, Cmte. Says
FDA should not replace AstraZeneca's Nolvadex (tamoxifen) with Novartis' Femara (letrozole) as the standard comparator for first-line hormonal drugs for the treatment of metastatic breast cancer, FDA's Oncologic Advisory Drugs Committee agreed Sept. 10.
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Time to progression should replace response rate as the primary endpoint in clinical trials for first-line hormonal drugs that treat metastatic breast cancer, FDA's Oncologic Drugs Advisory Committee said Sept. 10.
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials