FDA approves Amgen small cell lung cancer treatment | Wilnesh News

this Food and Drug Administration Approved Thursday Amgentreatment of patients deadliest form Lung cancer.

The agency approved the drug, which will be marketed under that name Imdetraas a second-line or follow-up treatment for people with advanced small cell lung cancer. This means that patients can take this drug if their cancer progresses during or after trying another form of treatment, usually 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 patients with small cell lung cancer significantly extend their lives.

Amgen stated that more than 2.2 million lung cancer patients are diagnosed with lung cancer worldwide every year, of which small cell lung cancer accounts for 15%, or 330,000 cases.About 80% to 85% People with small cell lung cancer were diagnosed with the advanced stages of the disease, according to a study published in the Journal of Cancer.

Dr. Jay Bradner, chief scientific officer of Amgen, told CNBC that there are approximately 35,000 patients with small cell lung cancer in the United States.

Small cell lung cancer usually starts in the airways of the lungs, growing up very fast, producing large tumors that spread throughout the body. Symptoms include blood in the phlegm, cough, chest pain and shortness of breath.

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

Lynne Bell, a small cell lung cancer patient from Atlanta, Georgia, is an exception. She said she felt “shocked” and “dark” in 2021 after she was diagnosed with the advanced stages of the disease.

But she started taking Amgen Imdetra ongoing clinical trials in September after other treatments, including chemotherapy, stopped working. Since then, Bell said, her tumor has shrunk significantly and her cancer scans “look great.” She said she specifically noticed her pain disappearing after taking her second dose of Amgen.

When asked how long it will last Imdetra“If this drug works and I don’t have any side effects, I’m good to go. I’m going to win,” Bell said.

Maida Mangiameli, a type of small cell lung cancer promote The patient mentor from Naperville, Illinois, is also a survivor of this devastating disease. She was diagnosed with terminal cancer in 2018 but was considered in remission this year, meaning the treatments 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 radiation therapy. She told CNBC that Amgen Imdetra Probably “not for me, but it might happen in the future.”

Mangiameli added that she is pleased to know that other patients with small cell lung cancer will have another treatment option. The development of new treatments for the disease has been “on the back burner” for years, she said.

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

“This is just one of the scariest cancers, so we need a new solution,” he said.

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

The approval is based on a result Phase 2 trial The study followed more than 200 patients with small cell lung cancer.Cancer tumors shrank in 40% of people taking the 10 mg dose Imdetra Once every two weeks.

Notably, the median survival time after people started taking 10 mg of Amgen’s drug was 14.3 months.compared with surroundings six to twelve months Current treatments, according to the National Cancer Institute.

“These patients, who normally only live four to five months, have almost an extra year of life,” Bradner told CNBC.

This time can make a huge difference for patients.

For Mangiameli, receiving treatment for small cell lung cancer allowed her to be closer to her grandson, who was born shortly before she was diagnosed with the disease.

“I was motivated, motivated to make sure I survived… I just had my first grandchild and I had to live long enough for us to be friends,” Mangiameli said.

At the same time, Bell said, Imdetra She was given time to travel; she traveled to San Diego with her daughter.

“I’m trying to go to as many places as possible,” Bell told CNBC.

Amgen is continuing research Imdetra In multiple trials, some of which will test the drug as an early treatment for small cell lung cancer.

including a late stage trial Compare Imdetra Chemotherapy is used as a second-line treatment for this disease.Amgen also plans to launch another Phase III study The drug is used as first-line treatment for patients with advanced small cell lung cancer.

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