Johnson & Johnson cell therapy has edge over Bristol-Myers Squibb rivals

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Hi guys!Two people compete cell therapy from Bristol-Myers Squibb and Johnson & Johnson got both good news Friday from the U.S. Food and Drug Administration.

But Johnson & Johnson’s drugs have significant advantages over rivals.

FDA expands approval of both therapyallowing patients to use them as an early treatment for a type of blood cancer called multiple myeloma. This can damage bones, immune system, kidneys and red blood cell count.

Prior to this decision, both Johnson & Johnson’s drug Carvykti and Bristol-Myers Squibb’s treatment Abecma were only available to people who had received at least one prior treatment Four specific drug regimens For incurable blood cancers.

First, expanding approval is an important step for patients.

They add more options to the growing arsenal of treatments and help improve outcomes for patients with multiple myeloma.people with the disease Often relapses occur or their cancer becomes resistant to one treatment, requiring them to switch to a different drug regimen.

These approvals will undoubtedly expand coverage of both therapies to thousands of eligible patients.New cases of multiple myeloma appear every year: more than 35,000 new cases According to Johnson & Johnson estimates, the United States will be diagnosed in 2024.

But the new approval also gives treatments developed by Johnson & Johnson and Legend Biotech a clear advantage over Bristol-Myers Squibb’s drug.

The FDA’s expanded approval means Carvykti can be used by patients after only one treatment for multiple myeloma, if certain conditions apply. Johnson & Johnson said early access to the drug may offer patients the potential for a treatment-free period earlier in the disease’s progression.

Under the new FDA approval, Bristol-Myers Squibb’s Abecma, jointly marketed by 2seventy bio, can be used after at least two regimens of multiple myeloma drugs.

The New York Stock Exchange welcomed the listing of Bristol Myers Squibb on November 20, 2020.

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Here’s what some analysts are saying: Product labeling differences between the two drugs provide Carvykti with a “significant commercial advantage,” Jefferies analyst Kelly Shi wrote in a note on Sunday.

Carvykti’s qualification as a second-line treatment for multiple myeloma “should limit” the use of other similar cell therapies in subsequent treatments, Shi said.

Carvykti and Abecma both belong to a class of personalized treatments called chimeric antigen receptor T cells, or cart – Therapy that attacks cancer by modifying white blood cells called T cells. Johnson & Johnson’s drug is gradually overtaking Abecma in the multiple myeloma CAR-T market, although the drug first entered the market a year later.

With Friday’s new approval, Jefferies’ Shi expects J&J’s drug to win most of the market share. The company believes Carvykti is “well-positioned” to eventually reach more than 80,000 patients in the U.S., EU and Japan as a second, third or fourth-line therapy.

The FDA’s expanded approval of Carvykti could also make it a blockbuster product for Johnson & Johnson.Last year, the drug was only available US$500 million The product leads global sales, according to Legend Biotech.

Cantor Fitzgerald analyst Rick Bienkowski wrote in a note Wednesday that the drug’s long-term opportunity could be about $8 billion per year, with expansion as a second-line treatment for multiple myeloma “a key segment to achieve this revenue.” market”. of approval.

Guggenheim analyst Kelsey Goodwin said Abecma’s peak annual sales could reach about $450 million, according to one company. Reuters interview last week.Bristol-Myers Squibb’s Drug Introduction $472 million Global Sales 2023.

But even with the new approval, both companies are still grappling with the same long-term problem: supply constraints.

Johnson & Johnson and Bristol-Myers Squibb have both outlined plans to increase production of their respective drugs. I’ll be watching how this part of the story unfolds later this year, so stay tuned.

Please feel free to send Annika any tips, suggestions, story ideas and data: annikakim.constantino@nbcuni.com.

Latest Healthcare Technology

A look at Mount Sinai’s approach to artificial intelligence

A sign hangs outside Mount Sinai Hospital on August 4, 2014 in New York City.

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On Monday, I toured part of the Mount Sinai Health System, which spans eight hospital campuses and a medical school, to learn how it uses generative artificial intelligence.

In a small corner of Mount Sinai Hospital that currently houses the School of Medicine’s Artificial Intelligence Department, I discussed current initiatives and future plans with senior executives, including plans to move the department into a new, larger building in June. building.

Although Mount Sinai, like many health systems, has been exploring the application of more traditional machine learning models for years, the organization has been looking closely at generative AI since OpenAI’s ChatGPT exploded in late 2022.

Dr. Bruce Darrow, the health system’s interim chief digital and information officer, said Mount Sinai is evaluating use cases in patient care, education and research. He said anything health systems can do to safely help clinicians and staff speed up decision-making in patient care is important.

For example, Mount Sinai’s radiologists (doctors who use medical images such as CT scans, MRIs, and X-rays to identify and treat conditions) are already using many new artificial intelligence tools. Dr. Laurie Margolies, director of breast imaging at Mount Sinai, said she comes into contact with three different artificial intelligence software tools in her daily work.

One tool assesses the entire mammogram, another assesses the breast ultrasound, and a third assesses image quality, which radiologists can use to check their technique and positioning, Margolis said. . While radiologists rely solely on computers, artificial intelligence can help provide additional reassurance, she said.

“I think it’s a health tool,” Margolis said. “I think it makes me more relaxed. When I think the mammogram is normal and the AI thinks it’s normal, I feel more confident about pressing the normal button.”

Despite continued hype and excitement about the potential of generative artificial intelligence in health care, Mount Sinai is trying to take a cautious approach to implementing it. Dr. David Reich, president of Mount Sinai Hospital and Mount Sinai Queen’s Hospital, said many of the initial use cases have been fairly quiet.

For example, one of the first places the technology was introduced was in Mount Sinai’s finance department, where Reich said people can now handle their bills more efficiently.

“We’d rather be slower, more monotonous and focus on workflow because we’re in a very serious business,” he said.

Determining which AI solutions are truly valuable can be challenging, Reich said, so Mount Sinai established a governance structure to help evaluate whether the use of tools is safe, feasible, practical and ethical. Most importantly, he said, the software needs to help solve real problems.

“A lot of people just want to sell algorithms,” Reich said.