China approved Amgen’s tarlatamab for previously treated small cell lung cancer, expanding access to the bispecific immunotherapy.
Amgen’s bispecific T-cell engager tarlatamab received regulatory approval in China, marking an important expansion for the company’s oncology portfolio into one of the world’s largest cancer markets.
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The approval, granted by China’s National Medical Products Administration and announced by development and commercialization partner BeOne Medicines, covers adult patients with extensive-stage small cell lung cancer whose disease has progressed following chemotherapy, an area of significant unmet need.1
Marketed in the United States as Imdelltra, tarlatamab is designed to target delta-like ligand 3 on tumor cells and CD3 on T cells, effectively redirecting the immune system to attack cancer.2
The therapy is part of Amgen’s broader strategy to advance bispecific antibodies, a class of immunotherapies that has gained traction for its ability to engage immune cells more precisely than traditional approaches. Imdelltra received
When FDA approved Imdelltra, Jay Bradner, M.D., executive vice president, Research and Development, at Amgen not the importance, "The FDA's decision reinforces Imdelltra as a recognized standard of care for people living with extensive stage small cell lung cancer whose disease progressed on or after frontline therapy. We are committed to delivering transformative medicines for patients facing challenging cancers, and we are currently focused on rapidly developing Imdelltra in earlier stages of disease and earlier lines of therapy for small cell lung cancer patients."
Clinical data supporting the approval highlights the therapy’s potential in a difficult-to-treat population. In the Phase II DeLLphi-301 study, tarlatamab demonstrated an objective response rate of 46.3% among previously treated patients, with a median duration of response of 7.2 months.3
Median progression-free survival was 5.4 months, while overall survival reached 19.0 months, suggesting a meaningful clinical benefit in a setting where treatment options remain limited.
Safety findings were also consistent with expectations for this class of therapy, with cytokine release syndrome beiing the most commonly reported adverse event, occurring in 48.8% of patients, though all cases were grade 1 or 2, and no patients discontinued treatment due to therapy-related side effects.3 These results indicate a manageable safety profile alongside durable responses, a combination that could support broader adoption in clinical practice.
Despite the approval, key commercial details, including launch timing and pricing in China, have not been disclosed.1 Neither Amgen nor BeOne Medicines responded to requests for additional information. However, analysts have pointed to strong market potential, with some estimating that Tarlatamab could generate more than $2 billion in annual sales globally if uptake meets expectations.1
China’s approval of Tarlatamab reflects a growing emphasis among multinational drugmakers on expanding access to innovative cancer therapies in international markets, particularly in Asia, where incidence rates for lung cancer remain high.
For Amgen, the decision also reinforces the strategic importance of partnerships in navigating regional regulatory and commercialization pathways.
