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  • Posted May 17, 2024

FDA Approves New Drug for Deadly Lung Cancer

The U.S. Food and Drug Administration on Thursday approved a new drug to treat patients with an advanced form of deadly lung cancer.

Importantly, tarlatamab (Imdelltra) is only for patients who have exhausted all other options to treat extensive-stage small cell lung cancer.

"The FDA's approval of Imdelltra marks a pivotal moment for patients battling [extensive-stage small cell lung cancer]," Dr. Jay Bradner, executive vice president of research and development and chief scientific officer at drug maker Amgen, said in a company news release. "Imdelltra offers these patients who are in urgent need of new innovative therapies hope, and we're proud to deliver this long-awaited effective treatment to them."

In a company trial, tarlatamab tripled patients' life expectancy, giving them a median survival of 14 months. But not everyone benefited: Forty percent of those who got the drug responded.

"After decades of minimal advancements in the [small cell lung cancer] treatment landscape, there is now an effective and innovative treatment option available," Laurie Fenton Ambrose, co-founder, president and CEO of GO2 for Lung Cancer, said in the Amgen news release.

Tarlatamab arrives after decades of no real treatment advances for 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 feel it's a light after a long time,” he told the New York Times.

Despite the drugs effectiveness, it does have a serious side effect called a cytokine release syndrome, the FDA said. That's when the immune system goes into overdrive, triggering symptoms like a rash, a rapid heartbeat and low blood pressure.

With small cell lung cancer, the disease has typically spread beyond the lung by the time it is diagnosed. The standard treatment is chemotherapy combined with immunotherapies that add about two months to patients' lives, the Times reported.

Most patients live just eight to 13 months after their diagnosis, despite having chemotherapy and immunotherapy. The patients in the Amgen trial had already had two or even three rounds of chemotherapy, which is why their life expectancy without the drug was so short.

Patients in the clinical trial say they have a new lease on life.

Martha Warren, 65, of Westerly, R.I., found out last year that she had small cell lung cancer. After chemotherapy and immunotherapy, with her cancer still spreading rapidly, she was accepted into the Amgen study and began getting infusions of the drug.

Her cancer began shrinking almost immediately.

“I feel as normal as I did before I had cancer,” Warren told the Times. “There's a lot of hope with this drug."

More information

Visit the National Cancer Institute for more on lung cancer.

SOURCE: U.S. Food and Drug Administration, news release, May 16, 2024; Amgen, news release, May 16, 2024; New York Times

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