Maurie Markman, MD
The debate continues: How can a new antineoplastic agent be approved for marketing if it has not been demonstrated in at least 1 well-designed phase III randomized clinical trial to offer a statistically significantly overall survival (OS) advantage? Is it possible to disagree with the simple logic that this endpoint must be the major aim of all antineoplastic agents, to improve the survival of patients receiving the drug? After all, isn’t this what patients want to achieve, the greatest possible duration of survival?
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