The Food and Drug Administration approved on Thursday Amgen's therapy for patients with the deadliest type of Lung cancer.
The agency has approved the drug to be marketed under that name Imdelltraas a second or later line of treatment for individuals with advanced small cell lung cancer. This means patients can take the drug if their cancer progresses during or after one other type of treatment, which is often chemotherapy. Amgen's drug can be known by the generic name tarlatamab.
Amgen's drug has been shown to work in clinical trials reduce tumor growth and help individuals with small cell lung cancer live significantly longer.
Of the greater than 2.2 million patients diagnosed with lung cancer every year worldwide, small cell lung cancer accounts for 15%, or 330,000 of those cases, Amgen said. About 80% to 85% of individuals with small cell lung cancer They are diagnosed with advanced stages of the disease, based on a study published within the Journal of Cancer.
There are roughly 35,000 patients with small cell lung cancer within the United States, said Dr. Jay Bradner, chief scientific officer of Amgen, told CNBC.
Small cell lung cancer normally begins within the airways of the lungs and grows quickly, causing large tumors to form and spread throughout the body. Symptoms include bloody mucus, cough, chest pain and shortness of breath.
Only 3% of patients According to the American Cancer Society, individuals with small cell lung cancer that has spread to other parts of the body live longer than 5 years. This five-year survival rate is 7% of all patients with this disease, no matter whether the cancer spreads. Bradner said patients with small cell lung cancer typically have 4 to 5 months to live.
An exception is Lynne Bell, a small cell lung cancer patient from Atlanta, Georgia. She says she was “horrified” and “in a dark place” after being diagnosed with a complicated stage of the disease in 2021.
But she began taking Amgens 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 said she particularly noticed that her pain subsided after taking a second dose of Amgen's drug.
When asked how long she would proceed ImdelltraBell said: “If this medication works and I don’t have any side effects, I’m good to go. I’m in it to win.”
Maida Mangiameli, a small cell lung cancer advocate and patient mentor from Naperville, Illinois, can be a survivor of the devastating disease. She was diagnosed with advanced stages of the disease in 2018, but was found to be in remission this 12 months, meaning the treatment she received has 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 Imdelltra could also be “not for me, but it could happen in the future.”
Mangiameli added that she is pleased that there shall be one other treatment option for other patients with small cell lung cancer. She said the event of recent treatments for the disease has been “on hold” for several years.
Amgen's Bradner also said 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.
Amgen's drug is named a bispecific T-cell engager, which is designed to redirect the immune system's T cells to acknowledge and kill cancer cells.
The approval relies on results of a Phase 2 study who followed greater than 200 patients with small cell lung cancer. Cancer tumors shrank in 40% of individuals given a 10-milligram dose of Imdelltra every two weeks.
Notably, the median time people lived after starting the 10-milligram dose of Amgen's drug was 14.3 months. This is comparable to about six to 12 months with current treatments, based on 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.
This time could make a giant difference for patients.
Treatment for her small cell lung cancer gave Mangiameli years to spend along with her grandchild, who was born shortly before she was diagnosed with the disease.
“I had the push, 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 it Imdelltra gave her the time to travel; She took a visit to San Diego along with her daughter.
“I try to go to as many places as possible,” Bell told CNBC.
Amgen continues to review Imdelltra in several studies, including some testing the drug as an earlier line of treatment for small cell lung cancer.
This includes one Late stage process compare Imdelltra with chemotherapy as second-line treatment for the disease. Amgen also plans to launch one other one Third phase study concerning the drug as a first-line treatment for patients with advanced stages of small cell lung cancer.
“What gives us confidence in developing cancer drugs is that if they work in later stages of the disease, they can work even better when moved to first-line therapy,” Bradner said.
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