The U.S. Food and Drug Administration (FDA) on Thursday approved a new drug to treat patients with advanced forms of deadly lung cancer.
Importantly, tarlatamab (Imdelltra) is only for patients who have exhausted all other treatment options for advanced small cell lung cancer.
"FDA approval of Imdelltra marks a turning point for patients battling [advanced small cell lung cancer]," said Dr. Jay Bradner, executive vice president of research and development and chief scientific officer of drugmaker Amgen, in company press release. "Imdelltra gives hope to these patients who are in dire need of new, innovative treatments, and we are proud to provide them with this long-awaited, effective treatment."
In the company's trials, tarlatamab tripled the life expectancy of patients, providing them with an average survival of 14 months. However, not everyone benefited from this: 40% of patients receiving the drug had a positive reaction.
“After decades of minimal advances in the treatment of [small cell lung cancer], an effective and innovative treatment is now available,” said Lori Fenton Ambrose, co-founder, president and CEO of GO2 for Lung Cancer, in an Amgen press release. p>
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.
Although the drug is effective, it has a serious side effect called cytokine release syndrome, the FDA said. This is a condition in which the immune system becomes overactive, causing symptoms such as rashes, 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 prolongs patients' lives by about two months, the Times reports.
Most patients live only eight to thirteen months after diagnosis, despite receiving chemotherapy and immunotherapy. Patients in Amgen's trials had already completed two or even three courses of chemotherapy, which explains their short life expectancy without the drug.
Patients in clinical trials say they have new hope for life.
Martha Warren, 65, of Westerly, Rhode Island, learned last year that she had small cell lung cancer. After chemotherapy and immunotherapy, as the cancer continued to spread rapidly, she was accepted into an Amgen study and began receiving drug infusions.
Her cancer began to shrink almost immediately.
"I feel as normal as I did before I was diagnosed with cancer," Warren told the Times. "This drug gives a lot of hope."