FDA approves treatment of small cell lung cancer with Amgen

The Amgen headquarters in Thousand Oaks, California.

Eric Thayer | Bloomberg | Getty Images

The Food and Drug Administration approved on Thursday Amgen's therapy for patients with the most deadly form of lung cancer.

The agency has approved the drug, which will be marketed under the name Imdelltraas a second or subsequent line of treatment for people with advanced small cell lung cancer. That means patients can use the drug if their cancer worsens during or after trying another form of treatment, usually a form of chemotherapy. Amgen's drug is also known by the generic name tarlatamab.

Amgen's drug has been shown to do this in clinical trials 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 comprises 15%, or 330,000, of those cases, Amgen said. All around 80% to 85% of people with small cell lung cancer 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 US, Dr. Jay Bradner, Amgen's chief scientific officer, told CNBC.

Small cell lung cancer usually starts in the airways of the lungs grows fast, causing large tumors to form and spread throughout the body. Symptoms include bloody mucus, coughing, chest pain and shortness of breath.

Only 3% of patients with small cell lung cancer that has spread to other parts of the body over the past five years, according to the American Cancer Society. That five-year survival rate is 7% among all patients with the condition, regardless of whether the cancer spreads. Amgen's 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 'shocked' and 'in a dark place' after she was diagnosed with an advanced stage of the condition 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 specifically noticed that her pain disappeared after taking a second dose of Amgen medication.

When asked how long she would continue with it ImdelltraBell 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 in favor and patient mentor from Naperville, Illinois, is also a survivor of the devastating disease. She was diagnosed with advanced stages of the condition in 2018, but this year she was thought to be in remission, meaning the treatment she received has reduced the signs and symptoms of the cancer.

Mangiameli completed treatment five years ago, which included chemotherapy and 28 days of radiation therapy. She told CNBC that's from Amgen Imdelltra may be “not for me, but it might happen in the future.”

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

Amgen's Bradner also said the 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 | Science 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 two trial who followed more than 200 patients with small cell lung cancer. Cancerous tumors shrank in 40% of people who received a 10-milligram dose Imdelltra every 2 weeks.

Strikingly, the average time people lived after starting 10-milligram doses of Amgen's drug was 14.3 months. That's comparable to approx six to twelve months with current treatments, according to the National Cancer Institute.

“These patients, who would normally only have four to five months, enjoy almost another full year of life,” Bradner told CNBC.

That time can make a big difference for patients.

For Mangiameli, treatment for small cell lung cancer gave her years to grow closer to her grandchild, who was born not long before she was diagnosed with the disease.

“I had the impulse, the drive to make sure I survived… I just had my first grandchild, I have to live long enough to be friends,” Mangiameli said.

Meanwhile, Bell said take it Imdelltra has given her time to travel, including on a trip with her daughter to San Diego.

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

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

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

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

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