FDA Clears Amgen's Imdelltra for Small Cell Lung Cancer Treatment

FDA Clears Amgen's Imdelltra for Small Cell Lung Cancer Treatment

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Amgen's Imdelltra (tarlatamab-dlle) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have experienced disease progression on or after platinum-based chemotherapy. This decision was influenced by the promising response rates and duration of response observed in clinical trials. Imdelltra, part of Amgen's bispecific antibody portfolio, is designed to bind both cancer cells and immune cells, facilitating an immune response to attack the cancer.

A mid-stage trial published in the New England Journal of Medicine revealed that 40% of patients treated with a 10 mg dose of tarlatamab every two weeks experienced tumor shrinkage. The FDA's approval, however, comes with a cautionary note as the drug's label includes a Boxed Warning for cytokine release syndrome and neurologic toxicities, including immune effector cell-associated neurotoxicity syndrome (ICANS). Further approval for this indication may depend on the outcomes and clinical benefits demonstrated in confirmatory trials.

The treatment cost for Imdelltra is estimated at $31,500 for the initial cycle, with subsequent infusions priced at $30,000, bringing the annual cost to approximately $781,500. With Amgen also exploring the drug's use in earlier-stage lung cancer, sales potential could exceed $2 billion annually if successful. The American Cancer Society estimates a five-year survival rate of about 7% among all patients with this condition, and only 3% of those with advanced disease live beyond five years, highlighting the urgency for new treatments in this area.


Other news in health