FDA Grants Accelerated Approval to Tarlatamab-dlle for Extensive Stage Small Cell Lung Cancer

SciFocus/MAy 22, 2024 -- In a significant advancement for cancer treatment, the U.S. Food and Drug Administration (FDA) has granted accelerated approval to tarlatamab-dlle (Imdelltra, Amgen, Inc.) for patients with extensive stage small cell lung cancer (ES-SCLC) who have experienced disease progression after platinum-based chemotherapy. This approval brings new hope to patients battling this aggressive form of cancer.

Efficacy and Safety Highlights:

- Clinical Trial Data: The approval is based on results from the DeLLphi-301 study, which enrolled 99 patients with relapsed/refractory ES-SCLC.

- Response Rates: The overall response rate (ORR) was 40%, with a median duration of response (DOR) of 9.7 months.

- Platinum-Resistant Patients: ORR was 52% in patients with progression within 90 days after the last platinum therapy dose.

- Platinum-Sensitive Patients: ORR was 31% in patients with progression 90 days or more after the last platinum therapy dose.

- Common Adverse Reactions: Includes cytokine release syndrome (CRS), fatigue, fever, taste changes, decreased appetite, musculoskeletal pain, constipation, anemia, and nausea.

- Laboratory Abnormalities: Common Grade 3 or 4 issues included decreased lymphocytes, sodium, potassium, hemoglobin, increased uric acid, and extended activated partial thromboplastin time.

Dosing and Administration:

- Initial Dose: 1 mg intravenously on Cycle 1 Day 1.

- Subsequent Doses: 10 mg on Cycle 1 Day 8 and Day 15, then every 2 weeks.

Expedited Review Programs:

- Project Orbis: The FDA collaborated with international regulatory agencies from Brazil, Canada, Israel, and the UK.

- Real-Time Oncology Review (RTOR): Allowed streamlined data submission, speeding up the review process.

- Assessment Aid: Facilitated the FDA's assessment and led to approval one month ahead of schedule.

Safety Warnings:

- Boxed Warning: Includes risks for serious or life-threatening CRS and neurologic toxicity, including ICANS.

Next Steps:

- Continued approval for tarlatamab-dlle will depend on the verification of clinical benefits in further studies.

The FDA's decision represents a promising development for ES-SCLC patients, offering a new treatment option after the failure of conventional therapies.

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