FDA approves Amgen small cell lung cancer treatment

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FDA approves Amgen small cell lung ******* treatment

The Amgen headquarters in Thousand Oaks, California.

Eric Thayer | Bloomberg | Getty Images

The

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on Thursday approved Amgen‘s therapy for patients with the

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of lung *******. 

The agency cleared the *****, which will be marketed under the name

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, as a second or later line of treatment for people with

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. That means patients can take the ***** if their ******* progresses while on or after trying one other form of treatment, which is typically a type of chemotherapy. Amgen’s ***** is also known by its generic name tarlatamab.

In clinical trials, Amgen’s ***** has been shown to

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and help people with small-cell lung ******* live significantly longer.

Of the more than 2.2 million patients who are diagnosed with lung ******* worldwide each year, small-cell lung ******* comprises 15%, or 330,000, of those cases, Amgen said. Around

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of people with small-cell lung ******* are diagnosed with an advanced stage of the ********, according to a study published in the Journal of *******.

There are around 35,000 patients with small-cell lung ******* in the U.S., Dr. Jay Bradner, Amgen’s chief scientific officer, told CNBC. 

Small-cell lung ******* usually starts in the airways of the lung and

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, creating large tumors and spreading throughout the body. Symptoms include ******* phlegm, cough, chest pain and shortness of breath.

Only

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with small-cell lung ******* that has spread to other parts of the body live past 5 years, according to the ********* ******* Society. That five-year survival rate accounts for 7% among all patients with the condition, regardless of whether the ******* spreads. Bradner said patients with small-cell lung ******* typically have four to five months to live.

Lynne Bell, a small-cell lung ******* patient from Atlanta, Georgia, is an exception. She says she was “horrified” and “in a dark place” after she was diagnosed with an advanced stage of the condition in 2021.

But she started taking Amgen’s

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in an ongoing clinical trial in September after other treatments, including chemotherapy, stopped working. Since then, Bell said her tumors have shrunk significantly and ******* scans “look great.” She said she specifically noticed her pain go away after taking a second dose of Amgen’s *****.

When asked how long she would continue

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, Bell said, “If this medication is working and I’m not having any side effects, I’m good to go. I’m in it to win it.”

Maida Mangiameli, a small-cell lung *******

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and patient mentor from Naperville, Illinois, is also a survivor of the devastating ********. She was diagnosed with an advanced stage of the condition in 2018 but was deemed in remission this year, meaning the treatment she received has reduced the signs and symptoms of the *******. 

Mangiameli completed treatment five years ago, which included chemotherapy and 28 days of radiation therapy. She told CNBC that Amgen’s

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may “not be something for me, but it might be down the road.” 

Mangiameli added that she’s excited to know that there will be another therapy option for other patients suffering from small-cell lung *******. She said the development of new treatments for the ******** has been “on the back burner” for several years. 

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

“It’s just one of the most dreadful cancers and so we needed a new solution,” he said. 

Lung ******* tumour and light micrograph, illustration. 

Kateryna Kon | Science Photo Library | Getty Images

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

The approval is based on results from a

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that followed more than 200 patients with small-cell lung *******. ******* tumors shrank in 40% of people who were given a 10-milligram dose of

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every 2 weeks.

Notably, the median time that people lived after starting 10-milligram doses of Amgen’s ***** was 14.3 months. That compares with around

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with current treatments, according to the National ******* 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 huge difference for patients. 

For Mangiameli, receiving treatment for small-cell lung ******* gave her years to get closer to her grandchild, who was born not long before she was diagnosed with the ********. 

“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 become pals,” Mangiameli said. 

Meanwhile, Bell said taking

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gave her the time to travel; she went on a trip with her daughter to San Diego.

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

Amgen is continuing to study

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in several trials, including some that will test the ***** as an earlier line of treatment for small-cell lung *******. 

That includes a

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comparing

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with chemotherapy as a second-line treatment for the ********. Amgen also plans to start another

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on the ***** as a first-line treatment for patients at an advanced stage of small-cell lung *******. 

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

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Business,Biotechnology,Biotech and Pharmaceuticals,Pharmaceuticals,Health care industry,Amgen Inc,Science,Breaking news,business news
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