J&J Cell Therapy Outperforms Competitor Bristol-Myers

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Hello guys! Two competing cell therapies from Bristol Myers Squibb And Johnson & Johnson Both got good news from the Food and Drug Administration on Friday.

But Johnson & Johnson's drug walks away with a noticeable advantage over its competitor.

The Food and Drug Administration has expanded approvals for both treatments, allowing patients to use them as first-line treatment for a type of blood cancer called multiple myeloma. This can damage your bones, immune system, kidneys, and red blood cell count.

Before this decision, Johnson & Johnson's Carvacti and Bristol-Myers' Abecma were only available to people who had previously received at least four specific drug regimens for incurable leukemia.

First and foremost, expanded approvals are a big step for patients.

They add more options to a growing arsenal of treatments that have helped improve outcomes for people with multiple myeloma. People with the disease often relapse or their cancer becomes resistant to one treatment, requiring them to switch to different drug regimens.

There is no doubt that the approvals will expand the reach of both treatments to thousands of eligible patients. New cases of multiple myeloma appear every year: More than 35,000 new cases will be diagnosed in 2024 in the United States, according to Johnson & Johnson estimates.

But the new approvals also give Johnson & Johnson's treatment, developed with Legend Biotech, a clear advantage over Bristol-Myers' drug.

The FDA's expanded approval states that patients can use Carvykti after only one line of treatment for multiple myeloma and if certain conditions apply. Johnson & Johnson said early access to the drug may offer patients the possibility of a treatment-free period early in the disease's progression.

Bristol-Myers' Abecma, co-marketed by 2seventy bio, can be given after at least two drug regimens to treat multiple myeloma, under new FDA approval.

Here's what some analysts are saying: The product label difference between the two drugs provides “a significant business advantage for Carvicti,” Jefferies analyst Kelly Shea wrote in a note Sunday.

Shi said Carvacity's eligibility as a second-line treatment for multiple myeloma “should limit the use” of other similar cell therapies in later lines of treatment.

Both Carvykti and Abecma belong to a class of personalized therapies known as chimeric antigen receptor T-cell therapies – or CAR-T – that work by modifying white blood cells known as T cells to attack cancer. Johnson & Johnson's drug has made incremental advances over Abecma in the CAR-T market for treating multiple myeloma, despite first entering the market a year later.

With Friday's new approval, Shea Jefferies expects J&J's drug to win the majority of that market share. The company believes Carvykti is “well positioned” to eventually reach more than 80,000 patients in the US, EU and Japan as a second, third or fourth line of treatment.

Expanded FDA approval for Carvykti could also put it on track to be a blockbuster product for J&J. Last year, the drug generated just $500 million in global sales, according to Legend Biotech.

The drug's long-term opportunity could be about $8 billion annually, and expansion as a second-line treatment for multiple myeloma makes it a “key market segment for generating these revenues,” Rick Binkowski, an analyst at Cantor Fitzgerald, wrote in a note on Wednesday. Of approval.

Peak annual sales of APICMA could reach about $450 million annually, according to a Reuters interview last week, Guggenheim analyst Kelsey Goodwin said. The Bristol-Myers drug generated $472 million in sales worldwide in 2023.

But even as they gain new approvals, both companies are grappling with the same long-term problem: supply constraints.

Both Johnson & Johnson and Bristol-Myers have outlined plans to boost production of their respective drugs. I'll be watching to see how this part of the story develops later this year, so stay tuned.

Feel free to send any tips, suggestions, story ideas and data to Annika at annikakim.constantino@nbcuni.com.

On Monday, I visited part of the Mount Sinai Health System, which spans eight hospitals and a medical school, to learn how it uses generative AI.

In a small corner of Mount Sinai Hospital that currently serves as the School of Medicine's AI department, I spoke with executives about current initiatives and plans for the future — including plans to move that particular department to a new, much larger building in June.

While Mount Sinai has been exploring applications of traditional machine learning models for years, like many health systems, the organization has been looking closely at generative AI since OpenAI's ChatGPT came on the scene at the end of 2022.

Mount Sinai is evaluating use cases across patient care, education and research, said Dr. Bruce Darrow, the health system's interim chief digital and informatics officer. In the context of patient care, anything the health system can do to safely help doctors and staff speed up the decision-making process is important, he said.

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 working with a number of new AI tools. Dr. Lori Margolis, director of breast imaging at Mount Sinai, said she is exposed to three different AI software tools in her daily work.

One tool can evaluate an entire mammogram, another can evaluate a breast ultrasound, and a third can evaluate image quality, which radiologists can use to check their technique and positioning, Margolis said. Although radiologists never turn to a computer, AI can help provide an extra layer of assurance, she said.

“I think it's a health tool,” Margolis said. “I think it makes me more relaxed. When I think a mammogram is normal, and the AI ​​thinks it's normal, I'm more confident in pressing that normal button.”

Despite the ongoing hype and excitement around the potential of generative AI in healthcare, Mount Sinai is trying to take a measured approach to its implementation. Many of the initial use cases have been fairly quiet, said Dr. David Reich, president of Mount Sinai and Mount Sinai Queens Hospital.

For example, one of the first places this technology was introduced was the finance departments at Mount Sinai, where Reich said people are now processing invoices more efficiently.

“We prefer to be more slow, lean and focused on workflow because we are in a very serious business,” he said.

It can be difficult to determine which AI solutions are actually worthwhile, Reich said, so Mount Sinai created a governance structure to help evaluate whether a tool is safe, feasible, practical and ethical to use. Above all, he said, the program needs to help address real problems.

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

Feel free to send any tips, suggestions, story ideas, and pitches to Ashley at ashley.capoot@nbcuni.com.