UK Grants Conditional Approval for Amgen’s Tarlatamab in SCLC
Amgen has announced that its bispecific antibody, IMDYLLTRA® (tarlatamab), has received conditional marketing authorization from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have progressed after at least two prior therapies, including platinum-based chemotherapy. This approval marks a major milestone in providing new therapeutic options for patients in the UK with this aggressive form of lung cancer.
Tony Patrikios, Executive Medical Director at Amgen UK & Ireland, highlighted the significance of this approval, stating, “The MHRA’s granting of a conditional marketing authorisation for tarlatamab is a significant step forward for people living with small cell lung cancer in the UK. With over 34,000 lung cancer-related deaths in the UK each year, there is an urgent need for new treatments, particularly for extensive-stage small cell lung cancer, where outcomes remain poor. This license brings us closer to offering a new treatment option to eligible patients in the UK.”
Small Cell Lung Cancer and the Need for New Treatment Options in the UK
Small cell lung cancer (SCLC) represents about 15% of lung cancer cases in the UK. Extensive-stage SCLC (ES-SCLC) is defined by rapid tumor growth and metastatic spread, often diagnosed in the UK at an advanced stage when symptoms are less noticeable. Even with initial chemotherapy, patients typically experience a short-lived response before the disease progresses. After several treatments, options for patients in the UK become limited.
The conditional marketing authorisation of tarlatamab is based on the Phase 2 DeLLphi-301 clinical trial. This trial tested tarlatamab in ES-SCLC patients in the UK who had failed at least two prior lines of therapy. Results showed that tarlatamab administered at a dose of 10 mg every two weeks resulted in an objective response rate (ORR) of 41% with a median duration of response (DoR) of 9.7 months.
How Tarlatamab Works
IMDYLLTRA (tarlatamab) is a bispecific T-cell engager that targets DLL3, a protein found on the surface of tumor cells in SCLC. By binding to both DLL3 and CD3 on T cells, tarlatamab activates T cells to release cytokines and cytotoxic proteins, which trigger the targeted destruction of tumor cells. This mechanism offers hope for patients in the UK with limited options who have relapsed after other treatments.
Side Effects and Monitoring in the UK
As with any medication, tarlatamab can cause side effects. The most common adverse events reported in the clinical trial included cytokine release syndrome (53.8%), pyrexia (fever, 36.9%), dysgeusia (taste alteration, 30%), and decreased appetite (29.4%). Other frequent side effects included constipation, fatigue, anemia, and asthenia. Patients in the UK will be closely monitored for these side effects, which may require intervention or treatment adjustments.
The Impact of Conditional Marketing Authorisation in the UK
The MHRA’s conditional marketing authorisation for IMDYLLTRA® represents a critical step forward for patients with advanced SCLC. However, this approval requires further evidence regarding the long-term safety and effectiveness of tarlatamab. As part of the authorization, the product will be subject to additional monitoring, ensuring that new safety information is quickly identified. Healthcare professionals are advised to report any suspected adverse reactions.
About Amgen and IMDYLLTRA®
Amgen, a global leader in biotechnology, focuses on the development of innovative therapies for serious diseases. Amgen is advancing treatments for cancer, heart disease, osteoporosis, and other conditions. IMDYLLTRA® (tarlatamab) is part of Amgen’s expanding pipeline, representing a promising new approach for treating ES-SCLC, a condition with a significant unmet need for effective therapies.
For more information on IMDYLLTRA®, healthcare professionals can refer to the Summary of Product Characteristics on the Medicines and Healthcare products Regulatory Agency website.
Conclusion
The conditional marketing authorization of IMDYLLTRA®is an important development for treating extensive-stage small cell lung cancer. With its innovative mechanism of action and encouraging clinical trial results, tarlatamab offers new hope for patients who have exhausted other treatment options. As more evidence becomes available, this therapy has the potential to become a vital addition to the treatment landscape for ES-SCLC .
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