The U.S. Food and Drug Administration (FDA) has approved a new drug, tarlatamab (Imdelltra), for treating patients with an advanced and deadly form of lung cancer.
Breakthrough Treatment for Small Cell Lung Cancer
This approval is particularly significant for those suffering from extensive-stage small cell lung cancer (ES-SCLC) who have exhausted all other treatment options. Dr. Jay Bradner, Executive Vice President of Research and Development and Chief Scientific Officer at Amgen, the drug’s manufacturer, highlighted the importance of this development. “The FDA’s approval of Imdelltra marks a pivotal moment for patients battling extensive-stage small cell lung cancer. Imdelltra offers these patients, who are in urgent need of new innovative therapies, hope. We are proud to deliver this long-awaited effective treatment to them,” he stated in a company news release.
Clinical Trial Success and Patient Impact
In clinical trials, tarlatamab significantly improved patient outcomes, tripling life expectancy with a median survival of 14 months. However, it’s important to note that not all patients benefited; only 40% of those who received the drug responded positively. Laurie Fenton Ambrose, co-founder, president, and CEO of GO2 for Lung Cancer, expressed optimism about the new treatment. “After decades of minimal advancements in the small cell lung cancer treatment landscape, there is now an effective and innovative treatment option available,” she said in Amgen’s news release. Dr. Anish Thomas, a lung cancer specialist at the National Cancer Institute, who was not involved in the trial, echoed this sentiment, describing the drug as “a light after a long time.”
Challenges and Side Effects
Despite its promise, tarlatamab comes with serious side effects, including cytokine release syndrome. This condition, which results from the immune system going into overdrive, can trigger symptoms such as rash, rapid heartbeat, and low blood pressure, according to the FDA. Typically, by the time small-cell lung cancer is diagnosed, it has already spread beyond the lungs. The standard treatment has been a combination of chemotherapy and immunotherapies, which extend patients’ lives by only about two months. Most patients live just eight to 13 months after diagnosis, even with these treatments. The patients in the Amgen trial had already undergone two or three rounds of chemotherapy, underscoring their dire need for new options.
A New Lease on Life for Patients
Patients participating in the clinical trial have reported dramatic improvements. Martha Warren, a 65-year-old from Westerly, Rhode Island, shared her experience. After being diagnosed with small cell lung cancer last year, Warren underwent chemotherapy and immunotherapy, but her cancer continued to spread rapidly. She was then accepted into the Amgen study and began receiving infusions of tarlatamab.
Her response to the treatment was swift and positive. “I feel as normal as I did before I had cancer,” Warren told the New York Times. “There’s a lot of hope with this drug.” The FDA’s approval of tarlatamab marks a significant milestone in the fight against extensive-stage small-cell lung cancer, providing much-needed hope and a potential new lease on life for patients who have had few options left.