(Reuters) -The U.S. Food and Drug Administration on Thursday granted accelerated approval to Amgen’s tarlatamab, a targeted immunotherapy for treating adults with advanced small cell lung cancer that has worsened despite chemotherapy.
The therapy, marketed under the name Imdelltra, is part of Amgen’s pipeline of bispecific antibodies, which are designed to attach to a cancer cell and an immune cell, bringing them together so that the body’s immune system can kill the cancer.
Results from a mid-stage trial published last year in the New England Journal of Medicine showed that tumors shrank in 40% of patients receiving 10 mg of tarlatamab by intravenous infusion every two weeks.
More than half of the patients whose tumors responded to tarlatamab did not see their disease worsen for at least six months.
The most common side effect was cytokine release syndrome, a potentially dangerous condition that occurs when the body’s immune system responds over aggressively to infection or immunotherapy drugs.
Most lung cancer cases are non-small cell, while up to 15%, according to the American Cancer Society, are the more aggressive small cell variety targeted by Amgen’s drug, tarlatamab.
The disease, which is diagnosed in about 35,000 U.S. patients annually, is “one of most rapidly proliferating and most aggressive cancers there is,” Jay Bradner, Amgen’s chief scientific officer, said in an interview ahead of the decision.
Bradner explained that the arm of tarlatamab that targets small cell lung cancer cells attaches to a protein called DLL3.
Amgen said it will need to complete its larger, pivotal trial in advanced small cell lung cancer to receive full FDA approval of the drug.
The company is also testing tarlatamab for treating patients with earlier stage small cell lung cancer.
If those studies prove successful, Wall Street analysts have said tarlatamab could represent an over $2 billion annual sales opportunity for the company.
(Reporting By Deena Beasley and Sneha S K; Editing by Bill Berkrot and Shailesh Kuber)
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