Bristol Myers: application validated for subcutaneous Opdivo
This validation is based on the results of CheckMate -67T, the first phase III trial of Opdivo's subcutaneous formulation to evaluate and demonstrate non-inferior pharmacokinetics and efficacy to its intravenous formulation.
It confirms that the application is complete and launches the EMA's centralized review procedure. This new formulation would enable patients to reduce administration time considerably, using a single injection in three to five minutes.
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