FDA approves Amgen's small cell lung cancer treatment

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

The agency authorized 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. That means patients can take the drug if the cancer progresses while receiving 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 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 each year worldwide, small cell lung cancer accounts for 15%, or 330,000, of those cases, Amgen said. About 80% to 85% of people with small cell lung cancer are diagnosed with an advanced stage of the 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 rapidly, creating large tumors and spreading throughout the body. Symptoms include bloody phlegm, cough, chest pain, and difficulty breathing.

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 more than 5 years. That five-year survival rate represents 7% among all patients with the condition, regardless of whether the cancer spreads. 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 condition in 2021.

But he started taking Amgen's Imdelltra in an ongoing clinical trial in September after other treatments, including chemotherapy, stopped working. Since then, Bell said his tumors have shrunk significantly and his cancer scans “look great.” He said he specifically noticed that her pain went away after taking a second dose of the Amgen medication.

When asked how long she would continue on Imdelltra, Bell said, “If this medication is working and I don't have any side effects, I'm ready to go. I'm here 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 condition in 2018, but this year she was considered to be in remission, meaning that 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 radiotherapy. She told CNBC that Amgen's Imdelltra may “not be a thing for me, but it might be in the future.”

Mangiameli added that he is excited to know that there will be another therapy option for other patients suffering from small cell lung cancer. He said the development of new treatments for the disease has been “on the back burner” for several years.

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

“It is one of the most terrible cancers and that is why we needed a new solution,” he said.

Amgen's drug is called bispecific T-cell activator, which is 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 shrank in 40% of people who received a 10-milligram dose of Imdelltra every 2 weeks.

Notably, the median time people lived after starting 10 milligram doses of Amgen's drug 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 have four to five months are enjoying almost another full year of life,” Bradner told CNBC.

That time can make a big difference for patients.

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

“I had the impetus, 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 gave him time to travel; She went on a trip with her daughter to San Diego.

“I'm trying to go to as many places as I can,” Bell told CNBC.

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

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

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