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The withdrawal of the FDA accelerated approval for locally advanced or metastatic urothelial carcinoma, a type of bladder cancer, does not affect other indications of the therapy.
The FDA withdrew Trodelvy for locally advanced or metastatic urothelial carcinoma; however, this does not affect other indication of the therapy.
Gilead Sciences announced the voluntary withdrawal of the Food and Drug Administration (FDA) accelerated approval of Trodelvy (sacituzumab govitecan-hziy) for the treatment of locally advanced or metastatic urothelial cancer, a type of bladder cancer, previously treated with platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor.
According to a press release from Gilead Sciences, the manufacturer of Trodelvy, the decision to withdraw the accelerated approval was made in discussion with the FDA. Gilead Sciences noted that this decision on urothelial cancer does not impact other indications of Trodelvy within or outside of the U.S.
Trodelvy received accelerated approval from the FDA in April 2021 for this specific indication, which was based on findings from the phase 2 TROPHY-U-01 study, which focused on findings related to the tumor response rate and duration of response. The FDA noted that the continued approval of Trodelvy for locally advanced or metastatic urothelial cancer would be contingent on the confirmatory TROPiCS-04 study.
Gilead Sciences provided an update on the TROPiCS-04 study in May 2024 via press release, noting that it did not meet the primary endpoint of overall survival. There was a numerical improvement in overall survival in the Trodelvy group, according to the May release, in addition to improvement trends in progression-free survival and overall response rate.
In addition, more patients assigned Trodelvy died from side effects as compared with those assigned treatment of physicians’ choice, most of which were associated with neutropenic complications including infection, according to the press release from the manufacturer. Findings from the TROPiCS-04 study will be presented at a future oncology meeting, according to the release on the approval withdrawal.
According to the ClinicalTrials.gov listing of the TROPiCS-04 study, researchers were anticipating on enrolling 696 patients with metastatic or locally advanced unresectable urothelial cancer whose disease progressed after a platinum-containing regimen and either PD-1 or PD-L1 therapy. Patients were randomly assigned to receive either Trodelvy or physician’s choice of treatment, which included Taxol (paclitaxel), Taxotere (docetaxel) or Javlor (vinflunine).
Trodelvy is an antibody-drug conjugate that is currently indicated for unresectable locally advanced or metastatic triple-negative breast cancer treated with two or more prior lines of systemic therapy, and unresectable locally advanced or metastatic HR-positive, HER2-negative breast cancer treated with endocrine-based therapy and two or more additional systemic therapies.
There is a Boxed Warning for Trodelvy regarding neutropenia and diarrhea. With a Boxed Warning, the FDA is alerting care teams and patients about serious or life-threatening side effects that may occur with a given treatment. These warnings also provide instructions to care teams on how best to manage the side effects including dose adjustments and what to monitor for.
The release noted that there are more than 20 clinical trials in progress assessing Trodelvy as a monotherapy or in combination with other therapies in several other solid tumors, including gynecological and lung cancers.
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