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FDA approves Amgen treatment for small cell lung cancer

Amgen headquarters in Thousand Oaks, California.

Eric Thayer | Bloomberg | Getty Images

The Food and Drug Administration approved Thursday Amgenis the therapy for patients with the deadliest form of lung cancer.

The agency authorized the drug, which will be marketed as Imdelltra, as a second or higher line of treatment for people with advanced small cell lung cancer. This means that patients can take the drug if their cancer progresses during or after trying another form of treatment, which is usually a type of chemotherapy. Amgen’s drug is also known by its generic name tarlatamab.

In clinical trials, Amgen’s drug was 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 each year worldwide, small cell lung cancer accounts for 15%, or 330,000 cases, Amgen said. About 80 to 85% of people with small cell lung cancer are diagnosed with advanced disease, according to a study published in the Journal of Cancer.

There are about 35,000 small cell lung cancer patients in the United States, Dr. Jay Bradner, Amgen’s chief scientific officer, told CNBC.

Small cell lung cancer usually starts in the airways of the lung and grows quickly, creating large tumors and spreading throughout the body. Symptoms include bloody phlegm, 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 live beyond 5 years. This five-year survival rate represents 7% among all patients with this disease, whether the cancer spreads or not. Bradner said patients with small cell lung cancer typically have four to five months to live.

Lynne Bell, a small cell lung cancer patient from Atlanta, Georgia, is an exception. 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 as part of an ongoing clinical trial in September after other treatments, including chemotherapy, stopped working. Since then, Bell said his tumors have shrunk significantly and the cancer scans “look great.” She said she specifically noticed that her pain disappeared after taking a second dose of the Amgen drug.

When asked how long she would continue Imdelltra, Bell said, “If this drug works and I don’t have any side effects, I’m good to go. I’m in it to win it.”

Maida Mangiameli, a small cell lung cancer advocate and patient mentor from Naperville, Illinois, is also a survivor of this devastating disease. She was diagnosed with an advanced stage of the disease in 2018, but was deemed to be 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 28 days of radiation therapy. She told CNBC that Amgen’s Imdelltra might be “not something for me, but it might be down the road.”

Mangiameli added that she was excited to know that there would be another treatment option for other patients suffering from small cell lung cancer. She said the development of new treatments for the disease had been “on the back burner” for several years.

Amgen’s Bradner also said treatment options “are pretty slim.”

“It is one of the most formidable cancers and so 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, designed to redirect the immune system’s T cells to recognize and kill cancer cells.

The approval is based on results from a phase two trial that followed more than 200 patients with small cell lung cancer. Cancerous tumors decreased in 40% of people who received a dose of 10 milligrams of Imdelltra every 2 weeks.

Notably, the median lifespan of people after starting 10-milligram doses of the drug 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 would normally only be four to five months old, are getting almost a full year of life,” Bradner told CNBC.

This time can make a huge difference for patients.

For Mangiameli, treatment for small cell lung cancer gave him years to become closer to his grandson, who was born shortly before the disease was diagnosed.

“I had the impulse, the will to ensure my survival. … I just had my first grandchild, I have to live long enough for us to become friends,” Mangiameli said.

During this time, Bell said that taking Imdelltra gave him time to travel; she went on a trip with her daughter to San Diego.

“I try to go to as many places as possible,” Bell told CNBC.

Amgen continues to study Imdelltra in several trials, some of which will test the drug as an early treatment for small cell lung cancer.

This includes a late-stage trial comparing Imdelltra to chemotherapy as a second-line treatment for the disease. Amgen also plans to launch another phase three study of the drug as a first-line treatment for patients with advanced small cell lung cancer.

“What gives us hope is that as you develop cancer drugs, if they work in later stages of the disease, they may work even better when you move them” to first-line treatment , Bradner said.

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