FDA approves supplemental efficacy application for AstraZeneca's Truqap
The regulator cleared a sixth supplement to Truqap's original approval, with an updated label issued the following day.
The FDA approved a supplemental new drug application for Truqap (capivasertib), sponsored by AstraZeneca, under a standard review priority. The submission was classified as an efficacy supplement, numbered as submission 6 under application number NDA218197.1
The submission status date is listed as September 16, 2026, and the application's status is marked as approved.
Truqap is available as an oral tablet in two strengths. The product comes in a 200 milligram tablet and a 160 milligram tablet, each containing capivasertib as the active ingredient.1
Documentation tied to this approval includes an approval letter dated September 21, 2026, and an updated product label dated September 22, 2026. Both documents were filed with the FDA's Center for Drug Evaluation and Research under the drugsatfda records system.1
The filing does not specify which indication or clinical data supported this particular efficacy supplement, nor does it detail changes made to the prescribing information beyond noting that a new label was issued. Readers seeking the specific clinical rationale or labeling changes should consult the linked approval letter and label documents directly, as the source record here provides only the administrative and regulatory tracking details of the supplement's approval.
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.