FDA approves Amgen’s treatment for deadliest form of lung cancer

The Food and Drug Administration approved on Thursday Amgentherapy for patients with the most lethal form lung cancer.

The agency approved the drug, which will be sold under the name Imdelltraas a second or later line of treatment for people with advanced compact cell lung cancer. This means that patients can take the medicine if their cancer progresses during or after trying another form of treatment, which is usually a type of chemotherapy. Amgen is also known by the generic name tarlatamab.

Amgen has been shown to work in clinical trials reduce tumor growth and aid people with compact cell lung cancer live much longer.

Amgen says that of the more than 2.2 million patients diagnosed with lung cancer each year worldwide, compact cell lung cancer accounts for 15%, or 330,000 cases. About 80% to 85% of people with compact cell lung cancer According to a study published in the Journal of Cancer, they were diagnosed with advanced stages of the disease.

As Dr. Jay Bradner, Amgen’s chief scientific officer, told CNBC, about 35,000 patients in the U.S. suffer from compact cell lung cancer.

Compact cell lung cancer usually starts in the airways of the lungs and grows quick, forming gigantic tumors and spreading throughout the body. Symptoms include bloody phlegm, cough, chest pain and shortness of breath.

Just 3% of patients According to the American Cancer Society, people with compact cell lung cancer that has spread to other parts of the body live longer than 5 years. This five-year survival rate is 7% among all patients with the disease, regardless of whether the cancer has spread. Bradner said patients with compact cell lung cancer typically have four to five months to live.

The exception is Lynne Bell, a compact cell lung cancer patient from Atlanta, Georgia. She says she was “terrified” and “in a obscure place” when she was diagnosed with advanced stages of the disease in 2021.

But she started taking Amgen Imdelltra in an ongoing clinical trial in September after other treatments, including chemotherapy, stopped working. Bell has since stated that her tumors have shrunk significantly and her tumor scans “look great.” She said she especially noticed pain relief after taking her second dose of Amgen.

When asked how long it will continue 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.”

Maida Mangiameli, compact cell lung cancer spokesman and patient mentor from Naperville, Illinois, is also a survivor of the debilitating disease. She was diagnosed with advanced-stage disease 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 treatment included chemotherapy and 28 days of radiotherapy. She told CNBC that Amgen Imdelltra maybe “it won’t be something for me, but it might happen in the future.”

Mangiameli added that she is excited to hear that another treatment option will be available for other compact cell lung cancer patients. She said that for several years, work on novel methods of treating this disease has remained on the sidelines.

Amgen’s Bradner also said treatment options “are quite modest.”

“It’s simply one of the scariest cancers, so we needed a novel solution,” he said.

Amgen’s drug is called a bispecific T-cell engager, which works to redirect the immune system’s T cells to recognize and kill cancer cells.

Approval is based on test results a phase two of the trial which involved over 200 patients with compact cell lung cancer. Cancerous tumors have shrunk in 40% of people given a 10-milligram dose of Imdelltra every 2 weeks.

Of note, the average survival time for patients after starting 10-milligram doses of Amgen was 14.3 months. For comparison, this is approximately from six to 12 months According to the National Cancer Institute, with current treatments.

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

This time can make a huge difference for patients.

In Mangiamela’s case, treatment for compact cell lung cancer gave her years to become closer to her grandson, who was born shortly before she was diagnosed with the disease.

“I had the momentum and motivation to make sure I survived. I just gave birth to my first grandchild. I have to live long enough for us to be buddies,” Mangiameli said.

Meanwhile, Bell said he was taking it Imdelltra he gave her time to travel; she went on a trip to San Diego with her daughter.

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

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

This includes: trial at a tardy stage comparison Imdelltra with chemotherapy as second-line treatment for this disease. Amgen also plans to launch another one phase three trial on the drug as a first-line treatment for patients with advanced-stage small-cell lung cancer.

“What gives us hope is that as we develop anticancer drugs, they will work even better when incorporated into first-line treatments if they work in the later stages of the disease,” Bradner said.