US Approves $780,000 Lung Cancer Drug
The U.S. Food and Drug Administration (FDA) has granted approval to tarlatamab-dlle, a treatment for metastatic small cell lung cancer (SCLC) priced at $780,000 for a year of treatment.
Immunotherapy Targeting
The drug, sold under the brand name Imdelltra, is a targeted immunotherapy that uses specific antibodies to bind to cancer cells and immune cells, guiding the immune system to attack the cancer. It is intended for adults with advanced stages of SCLC, a difficult-to-treat type of lung cancer.
Clinical Trial Results
Clinical trial results published in the New England Journal of Medicine showed a 40% reduction in tumors in patients receiving 10 mg of tarlatamab intravenously every two weeks.
High Cost
Manufacturer Amgen has set the U.S. price of the drug at $31,500 for the first treatment cycle and $30,000 for subsequent infusions. A year of therapy can cost up to $780,000, making it among the most expensive lung cancer drugs.
Types of Lung Cancer
Lung cancer is divided into two main types: small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC). NSCLC is the most common type (about 85%), while SCLC accounts for 15% of lung cancer diagnoses. Imdelltra is specifically targeting this group.
Aggressive Disease
"About 35,000 Americans get this disease every year," said Jay Bradner, Amgen's chief scientific officer. It is one of the fastest-growing and most aggressive forms of cancer.
Side Effects
The most common side effect observed in clinical trials was cytokine release syndrome, a condition that occurs when the immune system reacts excessively to an infection or immunotherapy drug.
Conditional Approval
Amgen has not yet received full FDA approval for the drug and needs to conduct more rigorous and larger trials in patients with extensive-stage SCLC. Currently, it has only received conditional approval.
Future Potential
The company is also testing tarlatamab in patients with earlier-stage SCLC. If these studies are successful, Wall Street analysts predict the drug could generate over $2 billion in annual sales for the company.