RE:RE:AstraZeneca's ADC disappoints - on severe adverse eventsApril 26, 2024 - After a negative phase 3 readout, Gilead Sciences is taking a $2.4 billion impairment charge on Trodelvy, TROP2-directed antibody-drug conjugate (ADC), which serves as the cornerstone of the company’s solid tumor ambition.
[Trodelvy was added to Gilead's product portfolio through the September 2020 acquisition of Immunomedics for US $21 Billion.] https://www.gilead.com/news-and-press/press-room/press-releases/2020/9/gilead-sciences-to-acquire-immunomedics
In January 2024 Gilead reported phase 3 trial that the TROP2-directed antibody-drug conjugate failed to significantly extend the lives of patients with previously treated non-small cell lung cancer compared with chemotherapy. Gilead is shoring up Trodelvy’s clinical data as AstraZeneca and Daiichi Sankyo are closing in on an FDA approval for their rival TROP2 ADC, datopotamab deruxtecan (Dato-DXd) in previously treated nonsquamous NSCLC. The FDA has set Dec. 20 as the target decision date.
The flurry of Trodelvy developments accentuates what Gilead CEO Dan O’Day called “a time of focused execution” at the big biotech.
Cell therapies, the other pillar of Gilead’s growing oncology portfolio, have recently reached a bottleneck. Sales from the CD19 CAR-Ts, Yescarta and Tecartus, have been relatively flat sequentially for the last three quarters. The two therapies together brought in $480 million in sales in the first quarter, versus $486 million in the third quarter of 2023 and $466 million in the last three months of the year. The FDA has installed new boxed warnings on the two CAR-T therapies’ labels reflecting a class-wide concern of secondary T-cell malignancies following the treatment of existing CAR-Ts.
The lack of growth momentum was the result of an infrastructure bottleneck at designated treatment centers. To solve the problem, Gilead is working to expand the number of authorized centers and affiliated satellites, while also driving increased referrals from community doctors, chief commercial officer, Johanna Mercier, said.
https://www.fiercepharma.com/pharma/gilead-writes-24b-trodelvy-ceo-underscores-time-focused-execution