Saturday, June 15, 2024

FDA Approves Amgen’s IMDELLTRA™ for Lung Cancer, Offering New Hope for Patients

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Amgen’s groundbreaking IMDELLTRA™ (tarlatamab-dlle) therapy has received the Food and Drug Administration (FDA) approval for the treatment of extensive-stage small cell lung cancer (ES-SCLC) in adult patients who have experienced disease progression on or after platinum-based chemotherapy. This milestone follows the encouraging results observed in clinical studies, which demonstrated a remarkable 40% objective response rate (ORR), a median duration of response (DoR) of 9.7 months, and a median overall survival (mOS) of 14.3 months in the pivotal DeLLphi-301 trial.

The approval of IMDELLTRA represents a significant advancement in the treatment landscape for ES-SCLC, offering hope to patients facing this aggressive and devastating disease. Developed as a DLL3-targeting Bispecific T-cell Engager therapy, IMDELLTRA activates the patient’s T cells to attack DLL3-expressing tumor cells, providing a highly targeted and effective treatment option. This innovative approach marks a departure from traditional chemotherapy regimens and opens new possibilities for patients who have exhausted standard treatment options.

Dr. Jay Bradner, Executive Vice President of Research and Development and Chief Scientific Officer at Amgen, emphasized the transformative potential of IMDELLTRA in addressing the urgent need for effective therapies in extensive-stage small cell lung cancer. He highlighted the therapy’s ability to deliver long-lasting responses in pretreated patients, underscoring its significance in improving patient outcomes.

IMDELLTRA™ Shows Strong Efficacy in Lung Cancer with Important Safety Considerations

The pivotal DeLLphi-301 trial, which formed the basis for IMDELLTRA’s accelerated approval, demonstrated compelling efficacy outcomes. Patients treated with IMDELLTRA at the 10 mg every two weeks dosing regimen achieved a robust ORR of 40% and a median DoR of 9.7 months. Importantly, the mOS reached 14.3 months, representing a substantial improvement compared to existing treatment options.

Despite these promising results, the safety profile of IMDELLTRA warrants careful consideration. The therapy carries warnings and precautions for cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS). Management of these adverse events is critical to ensuring patient safety and optimizing treatment outcomes. To support patients with extensive-stage small cell lung cancer, Amgen is committed to providing access to IMDELLTRA through various patient assistance programs. These initiatives aim to alleviate financial barriers and ensure that eligible patients can benefit from this innovative therapy.

Lung Cancer

IMDELLTRA™ Approval Marks Milestone in Immuno-Oncology for Lung Cancer and Beyond

In addition to its therapeutic implications, IMDELLTRA’s approval represents a significant milestone in the field of immuno-oncology. As the first and only DLL3-targeting Bispecific T-cell Engager therapy approved for extensive-stage small cell lung cancer, IMDELLTRA sets a precedent for the development of targeted immunotherapies across different cancer types.

Looking ahead, Amgen will continue to explore the potential of IMDELLTRA in ongoing clinical trials, including investigations in combination regimens and earlier lines of SCLC treatment. These efforts underscore Amgen’s commitment to advancing innovative therapies and improving outcomes for patients with cancer. In light of IMDELLTRA’s approval, Amgen will host a webcast investor call on May 20, 2024, to provide further insights into the therapy’s development and commercialization strategy. This event will offer stakeholders an opportunity to gain a deeper understanding of IMDELLTRA’s role in the evolving treatment landscape for extensive-stage small cell lung cancer.

In summary, the FDA approval of IMDELLTRA represents a significant breakthrough in the treatment of extensive-stage small cell lung cancer. With its innovative mechanism of action and compelling efficacy outcomes, IMDELLTRA offers new hope to patients and underscores the transformative potential of targeted immunotherapy in oncology.

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Resource: Amgen, May 16, 2024

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