The FDA approved Imdelltra (tarlatamab-dlle), also identified as tarlatamab and AMG 757, on May 16, 2024. The approval was recorded as an initial approval for Amgen Inc. and classified as a Type 1 new molecular entity.
Background
Tarlatamab is listed in the FDA record under the brand name Imdelltra and the name tarlatamab-dlle. The supplied data identify the product as a new molecular entity and name Amgen Inc. as the sponsor. They do not provide a drug class, mechanism of action, indication, patient population, dosing information, prior approval history, or prevalence figure.
Approval details
The event was an initial FDA approval associated with Biologics License Application BLA 761344. The record’s external identifier was BLA761344-ORIG-1. The FDA summary classified the application as “Type 1 - New Molecular Entity.”
What this means
The May 16, 2024, action established an FDA approval record for Imdelltra, the product name associated with tarlatamab-dlle. Based on the supplied data, the approval can be described as an initial approval and as a new-molecular-entity classification. The data do not specify the approved indication or provide clinical efficacy, safety, dosing, or comparative results, so those details cannot be assessed from this record.
Source
Source: FDA, Drugs@FDA overview record for Imdelltra (AMG 757), tarlatamab-dlle, Biologics License Application BLA 761344, dated May 16, 2024. Available at accessdata.fda.gov.