The Amgen headquarters in Thousand Oaks, California.
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The Food and Drug Administration gave approval Thursday Amgenis the therapy for patients with the deadliest form of lung cancer.
The agency approved the drug, marketed as Imdelltra, as a second or later line of treatment for people with advanced small cell lung cancer. This means patients can take the drug if their cancer progresses during or after another form of treatment, which is usually chemotherapy. Amgen's drug is also known by the generic name tarlatamab.
Amgen's drug has been shown in clinical trials to reduce tumor growth and help people with small cell lung cancer live significantly longer.
Of the more than 2.2 million patients diagnosed with lung cancer each year worldwide, small cell lung cancer accounts for 15%, or 330,000 of those cases, Amgen said. About 80 to 85 percent of people suffer from small cell lung cancer They are diagnosed with advanced stages of the disease, according to a study published in the Journal of Cancer.
There are approximately 35,000 patients with small cell lung cancer in the United States, said Dr. Jay Bradner, Amgen's chief scientific officer, told CNBC.
Small cell lung cancer usually begins in the airways of the lungs and grows rapidly, forming large tumors and spreading throughout the body. Symptoms include bloody mucus, cough, chest pain and shortness of breath.
According to the American Cancer Society, only 3% of patients with small cell lung cancer that has spread to other parts of the body survive longer than 5 years. This five-year survival rate is 7% of all patients with this disease, regardless of whether the cancer spreads. Bradner said patients with small cell lung cancer typically have four to five months to live.
An exception is Lynne Bell, a small cell lung cancer patient from Atlanta, Georgia. She says she was “horrified” and “in a dark place” after being diagnosed with an advanced stage of the disease in 2021.
But she started taking Amgen's Imdelltra in an ongoing clinical trial in September after other treatments, including chemotherapy, stopped working. Since then, Bell said her tumors have shrunk significantly and the cancer scans “look great.” She said she particularly noticed that her pain subsided after taking a second dose of Amgen's drug.
When asked how long she would continue Imdelltra, Bell said, “If this medication works and I don't have any side effects, then I'm good to go.” I’m going to win it.”
Maida Mangiameli, a small cell lung cancer advocate and patient mentor from Naperville, Illinois, is also a survivor of the devastating disease. She was diagnosed with advanced stages of the disease in 2018, but was found to be in remission this year, meaning the treatment she received has reduced the signs and symptoms of the cancer.
Mangiameli has been in remission for five years. Her treatments included chemotherapy and 28 days of radiation therapy. She told CNBC that Amgen's Imdelltra may “not be for me, but it could be in the future.”
Mangiameli added that she is pleased that there will be another treatment option for other patients with small cell lung cancer. She said the development of new treatments for the disease has been “on hold” for several years.
Amgen's Bradner also said treatment options are “pretty slim.”
“It's just one of the most terrible cancers and that's why we needed a new solution,” he said.
Lung cancer tumor and light micrograph, illustration.
Kateryna Kon | Scientific Photo Library | Getty Images
Amgen's drug is called a bispecific T-cell engager, which is designed to redirect the immune system's T cells to recognize and kill cancer cells.
The approval is based on the results of a phase 2 study in which more than 200 patients with small cell lung cancer were observed. Cancer tumors shrank in 40% of people given a 10-milligram dose of Imdelltra every two weeks.
Notably, the median time people lived after starting the 10-milligram dose of Amgen's drug was 14.3 months. According to the National Cancer Institute, current treatments last about six to 12 months.
“These patients who would normally only have four to five months are enjoying almost another full year of life,” Bradner told CNBC.
This time can make a big difference for patients.
Treatment for small cell lung cancer gave Mangiameli years to be closer to her grandchild, who was born shortly before she was diagnosed with the disease.
“I had the push, the drive to make sure I survived. … I just had my first grandchild, I have to live long enough for us to be friends,” Mangiameli said.
Meanwhile, Bell said taking Imdelltra has given her the time to travel; She took a trip to San Diego with her daughter.
“I try to go to as many places as possible,” Bell told CNBC.
Amgen continues to study Imdelltra in several studies, including some testing the drug as an earlier line of treatment for small cell lung cancer.
This includes a late-stage trial comparing Imdelltra with chemotherapy as a second-line treatment for the disease. Amgen also plans to begin another Phase 3 trial of the drug as a first-line treatment for patients with advanced small cell lung cancer.
“What gives us confidence in developing cancer drugs is that if they work in later stages of the disease, they can work even better when moved to first-line therapy,” Bradner said.
