On June 21, 2024, the FDA approved a supplemental application for Krazati (adagrasib). The FDA record identified the action as an efficacy supplement to NDA 216340, supplement 5, and listed BRISTOL as the sponsor.
Background
Adagrasib is listed in the record under the brand name Krazati. The supplied FDA entry classified the supplemental application as Efficacy. The data provided for this update did not include a mechanism of action, dosing information, disease indication, patient population, or details of prior approvals. Those details therefore cannot be established from this record alone.
What this means
The event represented an FDA approval of a supplemental application focused on efficacy. The record confirms the regulatory action and its date, but it does not provide clinical measurements, trial enrollment, comparator information, endpoint definitions, safety findings, or the specific efficacy evidence supporting the supplement. The approval should therefore be interpreted as a regulatory action documented in the FDA application record rather than as a report of trial results.
The supplied information also did not identify a new indication, an expanded patient population, a label warning, a contraindication, or a change to the product’s dosing. Any assessment of those elements would require additional FDA labeling or approval documents beyond the record cited here.
Source
Source: U.S. Food and Drug Administration, Drug Approval Details application overview for NDA 216340, showing supplemental application NDA216340-SUPPL-5 and an efficacy classification, dated June 21, 2024. Available at accessdata.fda.gov.