Gilead Halts Trodelvy Development for Bladder Cancer Treatment

Gilead Halts Trodelvy Development for Bladder Cancer Treatment

Gilead Halts Trodelvy Development for Bladder Cancer Treatment

Dive Brief:

  • Gilead has made the decision to cease the sale of its combination medication Trodelvy intended for bladder cancer treatment, as announced on Friday, following a mutual agreement with the FDA to withdraw it due to unsatisfactory trial outcomes.
  • Trodelvy received accelerated FDA approval for bladder cancer in 2021, based on results indicating it could reduce tumors in patients whose conditions had worsened after receiving chemotherapy and immunotherapy agents such as Merck & Co.’s Keytruda. Nevertheless, a follow-up study named TROPiCS-04 did not demonstrate an extension of survival for users of the medication.
  • The withdrawal of Trodelvy is part of a trend involving rescinded conditional approvals in recent times, particularly within the “PD-1” drug class, which includes Keytruda and Opdivo from Bristol Myers Squibb. However, the timing of Trodelvy’s withdrawal—just months after adverse trial results—indicates an increased vigilance from the FDA in addressing so-called “dangling” accelerated approvals.

Dive Insight:

Trodelvy plays a significant role in Gilead’s entry into oncology treatments. It is an antibody-drug conjugate designed to target a common protein prevalent in tumor cells, releasing a harmful chemical that affects only those cells while avoiding damage to healthy tissue.

Gilead’s leading oncology product is the cell therapy Yescarta, which primarily treats hematologic cancers such as lymphoma; on the other hand, Trodelvy addresses a range of solid tumors. While the recent setback in bladder cancer is disappointing, it constitutes a minor impact, accounting for less than 10% of sales compared to 90% from breast cancer, as noted by TD Securities analyst Tyler Van Buren in a communication to clients.

Van Buren anticipates Trodelvy sales to reach approximately billion by 2030, maintaining focus on its approved use in breast cancer.

Challenges have also arisen in Gilead’s lung cancer expansion efforts, spurred by disappointing clinical results comparing negatively against a competing drug from AstraZeneca and Daiichi Sankyo, which has successfully sought FDA approval for its product, datopotamab deruxtecan, in lung cancer treatment.

This year, Gilead expects crucial Trodelvy trial results from a Phase 3 study focused on a challenging variant of breast cancer known as “triple-negative.” Additionally, combinations of Trodelvy with Keytruda are advancing into late-stage clinical trials targeting both breast and lung malignancies.