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Tarlatamab rewrites treatment for small-cell lung cancer as approvals spread worldwide

Tarlatamab rewrites treatment for small-cell lung cancer as approvals spread worldwide

New Capabilities
By Newzino Staff |

A first-in-class immune therapy that redirects the body's T cells to attack tumors gains access in the world's two largest pharmaceutical markets within two years

Today: China grants conditional approval to tarlatamab

Overview

For decades, patients with extensive-stage small-cell lung cancer who relapsed after chemotherapy had almost nowhere to turn — five-year survival rates sat around 3%. Now a drug that physically bridges the patient's own immune cells to their tumor cells has been approved in both the United States and China, opening a new treatment class for one of the deadliest cancers. Tarlatamab, sold as Imdelltra, reduced the risk of death by 40% compared to standard chemotherapy in a confirmatory trial of 509 patients.

Why it matters

A cancer that killed nearly everyone who relapsed now has a treatment that cuts the risk of death by 40%, and it just reached 1.4 billion more people.

Key Indicators

40%
Reduction in risk of death vs. chemotherapy
Phase III DeLLphi-304 trial showed median overall survival of 13.6 months vs. 8.3 months for standard chemo
~3%
Five-year survival rate for extensive-stage SCLC
Among the lowest of any common cancer — the baseline tarlatamab aims to shift
160,000
Annual new SCLC diagnoses in China
Roughly 15% of all lung cancers diagnosed in the country each year
$627M
Imdelltra global sales in 2025
First full year of commercial availability in the United States
46.3%
Objective response rate in China trial
DeLLphi-301 trial data supporting the NMPA conditional approval

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People Involved

Robert A. Bradway
Robert A. Bradway
Leading Amgen's oncology expansion strategy
JO
John V. Oyler
Leading BeOne's China commercialization of tarlatamab

Organizations Involved

Amgen Inc.
Amgen Inc.
Biopharmaceutical Company
Developer of tarlatamab and originator of the BiTE platform

The world's largest independent biotech company, with $33.4 billion in 2024 revenue and an oncology franchise built around its proprietary bispecific T-cell engager technology.
BeOne Medicines (formerly BeiGene)
BeOne Medicines (formerly BeiGene)
Biopharmaceutical Company
Commercializing tarlatamab in China

A global oncology company headquartered in Basel, Switzerland, with deep commercial operations in China and 45+ countries.
National Medical Products Administration (NMPA)
National Medical Products Administration (NMPA)
Government Regulatory Agency
Approved tarlatamab through priority review pathway

China's drug regulatory authority, responsible for approving pharmaceuticals, medical devices, and cosmetics for the Chinese market.
U.S. Food and Drug Administration
U.S. Food and Drug Administration
Government Regulatory Agency
Granted traditional approval to tarlatamab in November 2025

The United States federal agency responsible for approving drugs and ensuring their safety and efficacy.

Timeline

  1. China grants conditional approval to tarlatamab

    Regulatory

    The NMPA approves tarlatamab through its priority review pathway for adult patients with extensive-stage SCLC who have progressed after platinum-based chemotherapy. It is the 13th innovative drug approved in China in 2026.

  2. EU medicines committee recommends approval

    Regulatory

    The Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending marketing authorisation for Imdylltra in the European Union.

  3. China codifies accelerated drug review pathways into law

    Regulatory

    The State Council formally elevates the NMPA's priority review, conditional approval, and breakthrough therapy pathways from departmental rules to administrative regulations.

  4. FDA converts to traditional approval

    Regulatory

    Based on the confirmatory Phase III survival data, the FDA grants full traditional approval to Imdelltra — the strongest form of regulatory endorsement.

  5. European Medicines Agency begins formal review

    Regulatory

    The EMA accepts Amgen's marketing authorisation application for tarlatamab (branded Imdylltra in Europe) for relapsed extensive-stage SCLC.

  6. Phase III trial shows 40% reduction in death risk

    Clinical Data

    The DeLLphi-304 trial reports that tarlatamab extended median overall survival to 13.6 months versus 8.3 months for standard chemotherapy in 509 patients with relapsed extensive-stage SCLC.

  7. FDA grants accelerated approval to Imdelltra

    Regulatory

    The FDA approves tarlatamab for extensive-stage small-cell lung cancer after platinum-based chemotherapy, based on the Phase II DeLLphi-301 trial showing a ~40% objective response rate. It is the first DLL3-targeting therapy ever approved.

  8. Amgen and BeiGene sign licensing deal for tarlatamab in China

    Partnership

    Amgen grants BeiGene (now BeOne Medicines) exclusive rights to develop and commercialize tarlatamab in mainland China, backed by a $2.7 billion equity investment.

Scenarios

1

Tarlatamab becomes standard of care worldwide and moves into first-line treatment

Discussed by: Wall Street oncology analysts, Amgen leadership, and clinical investigators running Phase III first-line trials

With US traditional approval secured, China approved, and EU approval expected by mid-2026, tarlatamab achieves broad global availability. Three ongoing Phase III trials testing tarlatamab in earlier treatment lines — including as a first-line therapy combined with chemotherapy and immunotherapy — report positive results, expanding the eligible patient population several-fold. Analysts project global sales exceeding $2 billion annually. This is the path Amgen is actively building toward.

2

Competing therapies erode tarlatamab's market share in second-line SCLC

Discussed by: Oncology researchers tracking Boehringer Ingelheim's obrixtamig and Daiichi Sankyo's ifinatamab deruxtecan

Boehringer Ingelheim's obrixtamig, which targets the same DLL3-CD3 mechanism, enters late-stage trials with a strategy of combining the drug with frontline chemotherapy from day one. Meanwhile, Daiichi Sankyo's antibody-drug conjugate ifinatamab deruxtecan — which targets a different protein (B7-H3) — has shown response rates above 50% and received FDA Breakthrough Therapy Designation. If either competitor demonstrates superior efficacy or a better safety profile, tarlatamab's first-mover advantage narrows.

3

China pricing negotiations limit commercial impact despite broad approval

Discussed by: Healthcare economists and pharmaceutical pricing analysts tracking China's National Reimbursement Drug List negotiations

While NMPA approval opens the door, actual patient access depends on tarlatamab's inclusion in China's National Reimbursement Drug List — a process that typically requires steep price discounts of 50-70% from list price. If pricing negotiations stall or the discount demanded makes the Chinese market less profitable than projected, BeOne and Amgen may face a gap between regulatory access and real-world patient access.

4

BiTE platform extends beyond lung cancer into broader solid tumors

Discussed by: Amgen R&D leadership and immunotherapy researchers studying DLL3 expression in other neuroendocrine cancers

DLL3 is expressed not only in small-cell lung cancer but also in other neuroendocrine tumors, including some colorectal, prostate, and bladder cancers. If ongoing early-stage trials of tarlatamab and next-generation BiTE molecules show activity in these tumor types, the platform's therapeutic reach could expand substantially — transforming the BiTE concept from a niche modality into a broad oncology tool.

Historical Context

Blinatumomab and the birth of BiTE therapy (2014)

December 2014

What Happened

Amgen's blinatumomab (Blincyto) became the first bispecific T-cell engager ever approved, targeting CD19 and CD3 to treat a rare blood cancer called B-cell acute lymphoblastic leukemia. The drug demonstrated that immune cells could be physically redirected to kill cancer cells using an engineered bridging molecule — a concept that had been theorized for decades but never successfully brought to patients.

Outcome

Short Term

Blinatumomab provided a new option for patients with a disease that had few effective treatments. It generated $1.6 billion in sales by 2025.

Long Term

The approval validated the entire BiTE platform and catalyzed a wave of bispecific antibody development across the pharmaceutical industry. It also revealed the platform's key limitation: it initially worked only in blood cancers where immune cells and tumor cells already coexist in the same space.

Why It's Relevant Today

Tarlatamab's approval represents the BiTE platform's leap from blood cancers into solid tumors — the much larger challenge that blinatumomab's success made possible but could not itself solve.

Checkpoint inhibitors enter SCLC treatment (2018-2019)

March 2019

What Happened

The FDA approved atezolizumab (Tecentriq) combined with chemotherapy as the first immunotherapy for extensive-stage small-cell lung cancer in March 2019, followed by durvalumab (Imfinzi) in March 2020. These PD-L1 checkpoint inhibitors marked the first meaningful change in SCLC first-line treatment in over two decades, extending median overall survival from roughly 10 months to about 12-13 months.

Outcome

Short Term

Checkpoint inhibitors became the new standard of care in first-line SCLC, but the survival gains were modest — only about two to three additional months compared to chemotherapy alone.

Long Term

The disappointingly small benefit highlighted SCLC's resistance to conventional immunotherapy approaches and intensified the search for fundamentally different treatment mechanisms, such as BiTE molecules and antibody-drug conjugates.

Why It's Relevant Today

Tarlatamab's 40% reduction in death risk in the second-line setting represents a far larger survival gain than checkpoint inhibitors achieved in the first line — underscoring why this new treatment class has generated such strong interest from regulators worldwide.

China's drug regulatory acceleration (2017-present)

2017-2026

What Happened

Beginning in 2017, China launched a series of regulatory reforms to close the years-long gap between when innovative drugs were approved in the US or Europe and when Chinese patients could access them. The NMPA introduced priority review pathways, accepted foreign clinical trial data, and joined the International Council for Harmonisation. By January 2026, the State Council elevated these accelerated pathways into formal law.

Outcome

Short Term

The approval lag for major drugs shrank from an average of 5-7 years to often less than 2 years. Multinational pharmaceutical companies began including China in global launch sequences rather than treating it as a delayed secondary market.

Long Term

China became the world's second-largest pharmaceutical market and a first-wave launch destination for many innovative drugs, reshaping global commercial strategies for major biotech companies.

Why It's Relevant Today

Tarlatamab's China approval came less than two years after US accelerated approval — a timeline that would have been impossible under the pre-reform regulatory system, and a concrete example of how these reforms translate into faster patient access.

Sources

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+4
Yicai Global U.S. Food and Drug Administration Amgen European Medicines Agency Pharmaphorum Morgan Lewis Mugglehead Oncology News Central Amgen Amgen