Key Takeaways:
Amgen won European Commission approval for Imdylltra (tarlatamab) to treat adults with extensive-stage small cell lung cancer who progressed after first-line platinum-based chemotherapy, the company said Monday.
The approval rests on data from the phase III DeLLphi-304 study, which showed the bispecific T-cell engager reduced the risk of death by 40% compared with standard-of-care chemotherapy. Patients on Imdylltra lived a median 13.6 months versus 8.3 months on chemo, a gain of more than five months, with a hazard ratio of 0.60 (95% CI: 0.47-0.77; p<0.001).
"Small cell lung cancer is one of the most aggressive solid tumors, with high rates of relapse following first-line treatment and limited treatment options," Jean-Charles Soria, senior vice president of Oncology at Amgen, said. "The European Commission's approval of Imdylltra, the first and only T-cell engager therapy approved to treat small cell lung cancer, marks an important step forward for patients in Europe."
The drug, already approved in the US under the brand name Imdelltra since May 2024, generated $258 million in first-quarter 2026 sales, up 219% from a year earlier and 10% sequentially. The Zacks Consensus Estimate projects 2026 sales of about $1.2 billion, nearly double the $627 million recorded in 2025.
Cytokine release syndrome, the most common adverse reaction, occurred in 56.7% of patients, with grade 3 or higher events in 1.9%. Serious CRS was reported in 19.7% of patients, primarily after the first two doses. The safety profile was consistent with prior studies, Amgen said.
The EU approval expands Imdylltra's commercial reach to a region with significant unmet need in small cell lung cancer, which accounts for 13% to 15% of more than 2.4 million lung cancer cases diagnosed worldwide each year. Amgen is running multiple phase III studies — including DeLLphi-305, DeLLphi-306 and DeLLphi-312 — evaluating the drug in earlier lines of treatment for both extensive-stage and limited-stage SCLC.
For Amgen shareholders, the approval adds a second major market for what is becoming a blockbuster oncology asset. The next catalyst to watch is data from the earlier-line trials, which could further expand the addressable patient population and support long-term sales growth beyond the $1.2 billion consensus estimate for 2026.
This article is for informational purposes only and does not constitute investment advice.
