Summary
On May 16, 2024, the Food and Drug Administration granted accelerated approval to tarlatamab-dlle (Imdelltra) for extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.
The FDA has approved a new drug called tarlatamab to treat a type of lung cancer called extensive-stage small cell lung cancer. Tarlatamab is given to patients who have already tried chemotherapy but whose cancer has come back or spread.
This new medicine is an antibody that targets a protein on cancer cells called DLL3. By attaching to DLL3, tarlatamab helps the body’s immune system find and destroy the cancer cells.
In a clinical trial, some patients who received tarlatamab had their tumors shrink or disappear for a period of time. This is an exciting new treatment option for patients with this difficult-to-treat cancer.
On May 16, 2024, the Food and Drug Administration granted accelerated approval to tarlatamab-dlle (Imdelltra, Amgen, Inc.) for extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.
Full prescribing information for Imdelltra will be posted here.
Efficacy and Safety
Efficacy was evaluated in 99 patients with relapsed/refractory ES-SCLC with disease progression following platinum-based chemotherapy enrolled in DeLLphi-301 [NCT05060016], an open-label, multicenter, multi-cohort study. Patients with symptomatic brain metastases, interstitial lung disease or non-infectious pneumonitis, and active immunodeficiency were excluded. Patients received tarlatamab until disease progression or unacceptable toxicity.
