Gilead Gains CHMP Nod for Trodelvy and Finalizes $5bn Tubulis Acquisition

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European CHMP granted positive opinion for Trodelvy as first-line therapy in metastatic triple-negative breast cancer patients ineligible for PD-(L)1 inhibitors. Gilead closed buyout of Tubulis for $5bn, paying $3.15bn upfront plus up to $1.85bn in milestones to expand its ADC portfolio, adding assets TUB-040 and TUB-030.

1. CHMP Positive Opinion for Trodelvy in TNBC Patients

The European CHMP granted a positive opinion to Trodelvy for use as a first-line treatment in metastatic triple-negative breast cancer patients who are not eligible for PD-(L)1 inhibitors. This recommendation, if adopted by the European Commission, could broaden Trodelvy’s label and boost Gilead’s oncology sales in Europe.

2. Completion of $5bn Tubulis Acquisition and ADC Expansion

Gilead closed its Tubulis acquisition for $5bn on a cash-free, debt-free basis, paying $3.15bn upfront and reserving up to $1.85bn in milestone payments. The deal brings next-generation ADC platforms, including assets TUB-040 and TUB-030, and establishes an ADC Innovation Center in Munich to accelerate ADC discovery, manufacturing, and clinical development.

Sources

PFB