Tecentriq (atezolizumab) received initial approval from the U.S. Food and Drug Administration (FDA) on May 18, 2016. This significant regulatory milestone designates atezolizumab as a Type 1 - New Molecular Entity, marking its first market entry and making it available for clinical use.
Background
The classification of atezolizumab as a Type 1 - New Molecular Entity by the FDA signifies that it contains an active ingredient that has not been previously approved or marketed in the United States. This designation is typically reserved for drugs that represent a new chemical or biological entity. The initial approval was granted to the sponsor, Genentech Inc., following the submission and review of Biologics License Application (BLA) 761034. This process involves a comprehensive evaluation of the drug's safety, efficacy, and manufacturing quality.
What this means
The initial FDA approval of Tecentriq (atezolizumab) on May 18, 2016, as a Type 1 - New Molecular Entity means that this novel biological agent is now available for prescription and clinical use in the United States. This event introduces a new therapeutic option into the medical landscape, providing clinicians with an additional tool for patient treatment. As a new molecular entity, atezolizumab represents an advancement in pharmaceutical development, offering a distinct mechanism of action or therapeutic approach compared to existing treatments.
Source
The information regarding this initial FDA approval was obtained directly from the U.S. Food and Drug Administration (FDA). The official approval for Biologics License Application (BLA) 761034 for Tecentriq (atezolizumab) was documented on May 18, 2016, and is publicly accessible through the FDA's drug approvals database on accessdata.fda.gov.