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FDA approves new drug for deadly lung cancer
Last reviewed: 02.07.2025
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The U.S. Food and Drug Administration (FDA) on Thursday approved a new drug to treat patients with an advanced form of deadly lung cancer.
Importantly, tarlatamab (Imdelltra) is only indicated for patients who have exhausted all other treatment options for extensive-stage small cell lung cancer.
"The FDA's approval of Imdelltra marks a turning point for patients battling [extensive small cell lung cancer]," said Dr. Jay Bradner, executive vice president of research and development and chief scientific officer at drug maker Amgen, in a company press release. "Imdelltra brings hope to these patients who desperately need new, innovative treatments, and we are proud to bring them this long-awaited, effective treatment."
In the company's trials, tarlatamab tripled the lifespan of patients, giving them a median survival of 14 months. However, not everyone benefited: 40% of patients who received the drug responded positively.
"After decades of minimal advances in [small cell lung cancer] treatment, an effective and innovative treatment option is now available," said Lori Fenton Ambrose, co-founder, president and CEO of GO2 for Lung Cancer, in an Amgen press release.
Tarlatamab comes after decades of no real advances in treating this type of lung cancer, said Dr. Anish Thomas, a lung cancer specialist at the National Cancer Institute who was not involved in the trial.
"I think this is the light at the end of a long tunnel," he told the New York Times.
While the drug is effective, it has a serious side effect called cytokine release syndrome, the FDA said. It's a condition in which the immune system becomes overactive, causing symptoms such as rash, rapid heartbeat and low blood pressure.
In small cell lung cancer, the disease has usually spread beyond the lung by the time it is diagnosed. The standard treatment is chemotherapy combined with immunotherapy, which extends patients' lives by about two months, the Times reports.
Most patients survive only eight to 13 months after diagnosis, despite undergoing chemotherapy and immunotherapy. The patients in the Amgen trial had already undergone two or even three rounds of chemotherapy, which explains their short life expectancy without the drug.
Patients who took part in clinical trials say they have new hope for life.
Martha Warren, 65, of Westerly, R.I., learned last year that she had small-cell lung cancer. After chemotherapy and immunotherapy, with the cancer continuing to spread rapidly, she was accepted into the Amgen study and began receiving infusions of the drug.
Her cancer began to shrink almost immediately.
"I feel as normal as I did before I had cancer," Warren told the Times. "This drug gives a lot of hope."