AMGN · 8-K · 20260804PR000124

Regulatory Approval Milestones

AMGEN INC · 2026-08-04 · Importance 38 · Surprise 60 · In source text

The European Commission approved IMDYLLTRA as monotherapy for adults with extensive-stage small-cell lung cancer after progression on or after first-line platinum-based chemotherapy. China’s NMPA granted full approval for second-line extensive-stage small-cell lung cancer, with BeOne designated to commercialize the product in China. TAVNEOS remains subject to an FDA request for voluntary U.S. market withdrawal, and Amgen requested a hearing and submitted supporting materials arguing for a favorable benefit-risk profile. FDA partial clinical holds paused enrollment in two subcutaneous blinatumomab studies, with discussions underway on reopening them.

Key facts

• In May, China NMPA granted full approval to IMDELLTRA for the treatment of second-line ES-SCLC and it will be commercialized by BeOne in China. source
• TAVNEOS was approved by the FDA in October 2021 and is indicated for adjunctive treatment of adult patients with severe active ANCA-associated vasculitis in combination with standard therapy including glucocorticoids. source

Impact estimates