Gilead Sciences reported Trodelvy’s Phase 3 test in metastatic urothelial cancer fell short of showing a statistically significant benefit on the overall survival main goal. The antibody drug conjugate had received accelerated FDA approval for this type of cancer in 2021.
Gilead Sciences said even though Trodelvy missed the main goal of its Phase 3 test in non-small cell lung cancer, the drug’s preliminary results show numerical improvement in patients whose disease did not respond to prior treatment with immunotherapy. The company plans to discuss with regulators a possible path forward in these patients.
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Gilead Sciences drug Trodelvy is now approved for treating patients whose breast cancer is classified as HR positive and HER2 negative, expanding use of the drug to a much wider group of patients. In other regulatory approval news, use of a Takeda Pharmaceutical rare disease drug has expanded to younger children.
Gilead Sciences has more detail about breast cancer drug Trodelvy, a blockbuster hopeful it acquired two years ago. Additional data from a pivotal study were presented during the annual meeting of the American Society of Clinical Oncology and they still leave many questions unanswered.
The deal marks Gilead's latest big-ticket move into oncology this year, with Immunomedics' Trodelvy anticipated to reach $4 billion in peak sales. However, at least one analyst suggested Gilead may have overpaid.