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Hello folks! Two competing cell therapies from Bristol Myers Squibb And Johnson & Johnson Both received good news from the Food and Drug Administration on Friday.
But J&J's drug has a significant lead over its competitor.
The FDA expanded approvals of both therapies, allowing patients to use them as earlier lines of treatment for a type of blood cancer called multiple myeloma. This can damage the bones, immune system, kidneys and red blood cell count.
Before this decision, J&J's Carvykti and Bristol Myers' Abecma were only available to people who had previously received at least four specific drug regimens for the incurable blood cancer.
The expanded approvals are, first and foremost, a big step for patients.
They add more options to the growing arsenal of treatments that have helped improve outcomes for people with multiple myeloma. people with the disease They often relapse or their cancer becomes resistant to treatment, requiring them to switch to other medications.
There is no doubt that the approvals will expand the reach of both treatments to thousands of eligible patients. New cases of multiple myeloma emerge every year: J&J estimates more than 35,000 new cases will be diagnosed in the United States in 2024.
The new approvals also give J&J's therapy developed with Legend Biotech a clear advantage over the drug from Bristol Myers.
The FDA's expanded approval says patients can use Carvykti after only one prior line of therapy for multiple myeloma and under certain conditions. J&J said earlier access to the drug could offer patients the opportunity for a treatment-free period earlier in disease progression.
Bristol Myers' Abecma, co-marketed by 2seventy bio, can be administered after at least two drug regimens for multiple myeloma under the new FDA approval.
The New York Stock Exchange welcomes Bristol Myers Squibb on November 20, 2020.
NYSE
Here's what some analysts are saying: The product label difference between the two drugs provides a “significant commercial advantage for Carvykti,” Jefferies analyst Kelly Shi wrote in a Sunday note.
Carvykti's suitability as a second-line treatment for multiple myeloma “should limit the use of other similar cell therapies in subsequent 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, which work by altering white blood cells, called T cells, to fight cancer fight. J&J's drug has gradually gained ground on Abecma in the CAR-T market for multiple myeloma, despite coming to market a year later.
With Friday's new approval, Jefferies' Shi expects J&J's drug to capture most of that market share. The company believes Carvykti is “well positioned” to ultimately reach more than 80,000 patients in the US, 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 become a blockbuster product for J&J. According to Legend Biotech, the drug only generated $500 million in global sales last year.
The drug's long-term opportunity could be around $8 billion a year, and expansion as a second-line treatment for multiple myeloma represents a “key market segment for generating these revenues,” Cantor Fitzgerald analyst Rick Bienkowski wrote in a note from Wednesday of 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' drug had global sales of $472 million in 2023.
But even with new approvals, the two companies are struggling with the same problem in the long term: delivery bottlenecks.
Both J&J and Bristol Myers have outlined plans to increase 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 tips, suggestions, story ideas and data to Annika at annikakim.constantino@nbcuni.com.
Latest health technology
A look at Mount Sinai's approach to AI
Signs hang outside Mount Sinai Hospital on August 4, 2014 in New York City.
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On Monday, I visited part of the Mount Sinai Health System, which includes eight hospital campuses and a medical school, to learn more about the use of generative artificial intelligence.
In a small corner of Mount Sinai Hospital, which currently serves as the medical school's AI department, I spoke with leaders about current initiatives and plans for the future—including plans to move that department to a much larger, brand-new building in June .
While Mount Sinai, like many health systems, has been exploring applications of more traditional machine learning models for years, the organization has been heavily involved in generative AI since OpenAI's ChatGPT launched 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. As part of patient care, anything the health system can do to help doctors and staff speed decision-making 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 medical conditions) are already working with a number of new AI tools. Dr. Laurie Margolies, head of breast imaging at Mount Sinai, said she is exposed to three different AI software tools in her daily work.
One tool can evaluate a complete mammogram, another can evaluate a breast ultrasound exam, and the third assesses image quality, allowing radiologists to check their technique and positioning, Margolies said. While radiologists never simply rely on the computer, AI can help provide an additional layer of security, she said.
“I think it’s a wellness tool,” Margolies said. “I think it makes me a lot more relaxed. If I think a mammogram is normal and the AI thinks it’s normal, I’ll be more confident when I press the normal button.”
Despite the ongoing hype and excitement surrounding the potential of generative AI in healthcare, Mount Sinai is trying to take a measured approach to implementation. Dr. David Reich, president of Mount Sinai Hospital and Mount Sinai Queens, said many of the early use cases have been quiet.
For example, one of the first places the technology was rolled out was in Mount Sinai's finance departments, where Reich said people are now processing invoices more effectively.
“We would rather go a little slower and more laborious and focus on workflow because we are in a very serious business,” he said.
Reich said it can be difficult to determine which AI solutions are actually worthwhile. That's why Mount Sinai has established a governance structure to assess whether a tool is safe, feasible, practical and ethical. Above all, the software must help address real problems, he said.
“A lot of people just want to sell an algorithm,” Reich said.
Feel free to send tips, suggestions, story ideas and data to Ashley at ashley.caroot@nbcuni.com.
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