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Hi folks! Two competing cell therapies from Bristol Myers Squibb and Johnson & Johnson both got good news from the Food and Drug Administration on Friday.
But J&J's drug is walking away with a notable edge over its rival.
The FDA expanded the approvals of both therapies, allowing patients to use them as earlier lines of treatment for a type of blood cancer called multiple myeloma. That can damage the bones, immune system, kidneys and red blood cell count.
Before that decision, J&J's drug Carvykti and Bristol Myers's treatment Abecma were both only available to people who previously received at least four specific drug regimens for the incurable blood cancer.
First and foremost, the expanded approvals are a major 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's no doubt that the approvals will expand the reach of both treatments to thousands of eligible patients. New cases of multiple myeloma crop up each year: More than 35,000 new cases will be diagnosed in 2024 in the U.S., according to J&J's estimates.
But the new approvals also give J&J's therapy, which was developed with Legend Biotech, a clear advantage over Bristol Myers's drug.
The FDA's expanded approval says patients can use Carvykti after just one prior line of therapy for multiple myeloma and if certain conditions apply.
Bristol Myers's Abecma, which is co-marketed by 2seventy bio, can be administered after at least two drug regimens for multiple myeloma, under the new FDA approval.
Here's what some analysts are saying: The product label difference between the two drugs offers a "significant commercial advantage for Carvykti," Jefferies analyst Kelly Shi wrote in a Sunday note.
Carvykti's eligibility as a second-line treatment for multiple myeloma "should limit the use" of other similar cell therapies in the following lines of therapy, Shi said.
Both Carvykti and Abecma belong to a class of personalized treatments known as chimeric antigen receptor T-cell – or CAR-T – therapies that work by modifying white blood cells known as T-cells to attack cancer. J&J's drug has gradually gained ground over Abecma in the CAR-T market for multiple myeloma, even though it first entered the market a year later.
With the new approval on Friday, Jefferies' Shi expects J&J's drug to win the majority of that market share. The firm 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 of therapy.
The FDA's expanded approval of Carvykti could also put it on track to be a blockbuster product for J&J. Last year, the drug pulled in just $500 million in worldwide sales, according to Legend Biotech.
The drug's long-term opportunity could be around $8 billion a year, and the expansion as a second-line treatment for multiple myeloma makes for a "key market segment for achieving this revenue," Cantor Fitzgerald analyst Rick Bienkowski wrote in a Wednesday note ahead of the approval.
Guggenheim analyst Kelsey Goodwin said Abecma's peak annual sales could be around $450 million a year, according to a Reuters interview last week. Bristol Myers's drug brought in $472 million in worldwide sales in 2023.
But even with new approvals under their belts, the two companies are grappling with the same long-term issue: supply constraints.
Both J&J and Bristol Myers have outlined plans to boost production of their respective drugs. I'll be watching to see how that part of the story plays out later this year, so stay tuned.
Feel free to send any tips, suggestions, story ideas and data to Annika at annikakim.constantino@nbcuni.com.
Latest in health-care technology
A look at Mount Sinai's approach to AI
On Monday, I visited part of the Mount Sinai Health System, which spans eight hospital campuses and a medical school, to learn about how it's using generative artificial intelligence.
In a small corner of The Mount Sinai Hospital that currently serves as the med school's AI department, I spoke with executives about current initiatives and plans for the future – including plans to move that very department to a much larger, brand new building in June.
While Mount Sinai has been exploring applications of more traditional machine learning models for years, like many health systems, the organization has been looking closely at generative AI since OpenAI's ChatGPT exploded onto the scene at the end of 2022.
Dr. Bruce Darrow, the health system's interim chief digital and information officer, said Mount Sinai is evaluating use cases across patient care, education and research. Within patient care, anything the health system can do to safely help clinicians and staff speed up decision making is important, he said.
For instance, Mount Sinai's radiologists (doctors who use medical images like CT scans, MRIs and X-rays to identify and treat conditions) are already working with a number of new AI tools.
Dr. Laurie Margolies, director of breast imaging at Mount Sinai, said she is exposed to three different AI software tools in her day-to-day work.
One tool can evaluate an entire mammogram, another can evaluate a breast ultrasound and the third evaluates image quality, which radiologists can use to check on their technique and positioning, Margolies said. While radiologists don't ever just defer to the computer, she said, AI can help provide an extra layer of assurance.
"I think it's a wellness tool," Margolies said. "I think it's making me much more relaxed. When I think a mammogram is normal, and the AI thinks it's normal, I'm more confident hitting that normal button."
Despite the ongoing hype and excitement around generative AI's potential in health care, Mount Sinai is trying to take a measured approach to its implementation. Dr. David Reich, president at The Mount Sinai Hospital and Mount Sinai Queens, said a lot of the initial use cases have been rather quiet.
One of the first places the technology was introduced, for instance, was in Mount Sinai's financial departments, where Reich said people are now processing bills more effectively.
"We'd rather be a little bit more slow and plodding and workflow-focused because we're in a very serious business," he said.
Reich said it can be challenging to determine which AI solutions are actually worthwhile, so Mount Sinai has established a governance structure to help assess whether a tool is safe, feasible, practical and ethical to use. Above all else, the software needs to help address real problems, he said.
"A lot of people just want to sell an algorithm," Reich said.
Feel free to send any tips, suggestions, story ideas and data to Ashley at ashley.capoot@nbcuni.com.
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