The U.S. Food and Drug Administration (FDA) approved a supplemental efficacy application for Tecentriq (atezolizumab) on December 6, 2018. This approval, designated as BLA 761034 S-9, was submitted by sponsor Genentech Inc. and specifically pertained to the drug's efficacy profile.
Background
Atezolizumab, marketed as Tecentriq, is a therapeutic agent developed by Genentech Inc. The drug falls under the "Efficacy" class, indicating its primary function in demonstrating therapeutic benefit. This supplemental application built upon existing knowledge regarding the drug's effectiveness.
What this means
A supplemental efficacy approval for Tecentriq (atezolizumab) signifies that the FDA has reviewed and accepted additional data supporting the drug's effectiveness. While the specific details of the new efficacy data are not provided in this regulatory summary, such approvals typically lead to updates in the drug's official prescribing information. These updates can clarify, expand upon, or reinforce the demonstrated benefits of the drug for patients in its approved indications. For clinicians, this reinforces the evidence base for using atezolizumab, ensuring that its known efficacy profile is robust and up-to-date according to regulatory standards. Patient advocates and researchers can view this as a further validation of the drug's role in treatment paradigms, prompting closer examination of the specific data that led to this updated assessment.
Source
The information regarding this supplemental approval was obtained from the U.S. Food and Drug Administration (FDA) website. The approval for supplemental application BLA 761034 S-9, concerning Tecentriq (atezolizumab), was documented on December 6, 2018, on accessdata.fda.gov.