Amgen headquarters in Thousand Oaks, California.
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The Food and Drug Administration approved it Thursday AmgenA treatment for patients with the most lethal form of lung cancer.
The agency has approved the drug, which will be marketed under the name Imdelltra, as a second or subsequent line of treatment for people with advanced small-cell lung cancer. This means that patients can take the drug if their cancer develops during or after trying another form of treatment, which is usually a type of chemotherapy. Amgen is also known by its generic name tarlatamab.
In clinical trials, Amgen has been shown to reduce tumor growth and help people with small cell lung cancer live much longer.
Of the more than 2.2 million patients diagnosed with lung cancer worldwide each year, small cell lung cancer accounts for 15%, or 330,000 cases, of those cases, Amgen said. About 80% to 85% of people with small-cell lung cancer are diagnosed with advanced stage disease, according to a study published in the journal Cancer.
Dr. Jay Bradner, Amgen's chief scientific officer, told CNBC that there are about 35,000 patients with small cell lung cancer in the United States.
Small cell lung cancer usually starts in the bronchial tubes of the lung and grows rapidly, creating large tumors and spreading throughout the body. Symptoms include bloody phlegm, cough, chest pain, and shortness of breath.
Only 3% of patients with small-cell lung cancer that has spread to other parts of the body live more than 5 years, according to the American Cancer Society. The five-year survival rate is 7% among all patients with this condition, regardless of whether the cancer spreads or not. Patients with small cell lung cancer typically have four to five months to live, Bradner said.
Lynn Bell, a small-cell lung cancer patient from Atlanta, Georgia, is an exception. She says she felt “terrified” and “in a dark place” after she was diagnosed with an advanced stage of the condition in 2021.
But she started taking Amgen's Imdeltra drug in an ongoing clinical trial in September after other treatments, including chemotherapy, stopped working. Since then, Bell said her tumors have shrunk significantly and her cancer screenings “look great.” Specifically, she said she noticed her pain disappearing after taking a second dose of Amgen.
When asked how long she would continue taking Emdeltra, Bell said: “If this medication works and I don't have any side effects, I'm willing to continue with it. I'm in it to win it.”
Maeda Mangiamelli, a small cell lung cancer advocate and patient navigator from Naperville, Illinois, is also a survivor of this devastating disease. She was diagnosed with an advanced stage of the condition in 2018 but was considered in remission this year, meaning the treatment she received reduced the signs and symptoms of the cancer.
Mangiameli has been in remission for five years. Her treatments included chemotherapy and radiotherapy for 28 days. Amgen's Imdelltra “may not be my thing, but it may be in the future,” she told CNBC.
Mangiameli added that she is excited to know 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 had been “lagging behind” for several years.
Amgen's Bradner also said treatment options are “very slim.”
“It's just one of the most dangerous types of cancer so we need a new solution,” he said.
Lung cancer tumor and light micrograph, illustration.
Katrina Kuhn | Science Picture Library | Getty Images
Amgen's drug is called a dual-specific T-cell interactor and is designed to redirect T cells in the immune system to recognize and kill cancer cells.
The approval is based on the results of a phase 2 trial that followed more than 200 patients with small cell lung cancer. Cancerous tumors shrank in 40% of people who were given a 10-milligram dose of Imdeltra every two weeks.
Notably, the average time people lived after starting 10-milligram doses of Amgen was 14.3 months. That compares to about six to 12 months with current treatments, according to the National Cancer Institute.
“These patients who normally only have four to five months are enjoying another full year of life,” Bradner told CNBC.
This time can make a big difference for patients.
For Mangiameli, receiving treatment for small cell lung cancer gave her years to be close to her grandson, who was born shortly before she was diagnosed with the disease.
“I had the drive and motivation to make sure I survived. I had just given birth to my first grandchild, and I had to live long enough for us to be friends,” Mangiameli said.
In the meantime, Bell said taking Emdeltra gave her time to travel; She went on a trip with her daughter to San Diego.
“I try to go to as many places as I can get to,” Bell told CNBC.
Amgen continues to study Emdeltra in several trials, including some that will test the drug as a first-line treatment for small cell lung cancer.
This includes a late-stage trial comparing Imdeltra with chemotherapy as a second-line treatment for the disease. Amgen also plans to initiate another Phase 3 study of the drug as a first-line treatment for patients with advanced NSCLC.
“What makes us optimistic is that as cancer drugs are developed, if they work in later stages of the disease, they can work even better when moved” to first-line treatment, Bradner said.
