Was Trodelvy’s bladder cancer indication withdrawn, and when?
Trodelvy (sacituzumab govitecan) had a bladder cancer indication in earlier U.S. approvals, but Gilead’s current prescribing information no longer lists bladder cancer as an approved indication. That implies the approval for this use was withdrawn (or superseded) before the current label.
However, the specific “withdrawn date” is not provided in the information available here. To give an exact date, I would need the relevant FDA label history entry, an FDA withdrawal/label-change notice, or Gilead’s regulatory timeline for the bladder cancer indication.
What should I check to find the exact withdrawal date?
The most direct sources to confirm the exact withdrawn date are:
- FDA’s labeling history for Trodelvy (changes to indications over time).
- FDA communications tied to indication withdrawal or restriction (often via press releases, safety communications, or supplemental approvals that remove an indication).
- Gilead’s regulatory updates and the indication section in archived versions of the U.S. prescribing information.
Why would a bladder cancer indication be removed even if the drug still exists?
Indications can be withdrawn when:
- Confirmatory or confirmatory-study requirements are not met.
- Evidence changes after additional trials, or the benefit-risk profile no longer supports that specific use.
- Regulatory decisions are updated to reflect new data or to align the label with what regulators accept.
If you share the jurisdiction (U.S., EU, UK, or another country) and whether you mean “withdrawn from the label” versus “withdrawn from marketing,” I can narrow down what the correct “withdrawn date” should refer to and what document typically contains it.
Quick clarification (so I can pinpoint the date)
Which label and geography do you mean by “withdrawn date”?
- U.S. FDA label, or another regulator?
And are you looking for the date:
- the indication was removed from the prescribing information, or
- the date the company stopped marketing/selling for bladder cancer?
Sources: none provided in the prompt.