Jonathan Raa | Nurphoto | Getty Images
Think a friend or colleague needs to be getting this article? Share this link with them to enroll.
Hi folks! Two competing cell therapies from Bristol Myers Squibb and Johnson & Johnson each got excellent news from the Food and Drug Administration on Friday.Â
But J&J’s drug is walking away with a notable edge over its rival.
The FDA expanded the approvals of each therapies, allowing patients to make use of them as earlier lines of treatment for a style of blood cancer called multiple myeloma. That may damage the bones, immune system, kidneys and red blood cell count.
Before that call, J&J’s drug Carvykti and Bristol Myers’s treatment Abecma were each only available to individuals who previously received not less than 4 specific drug regimens for the incurable blood cancer.Â
Initially, the expanded approvals are a significant step for patients.Â
They add more options to a growing arsenal of treatments which have helped improve outcomes for individuals with multiple myeloma. Individuals with the disease often relapse or their cancer becomes proof against one treatment, requiring them to modify to different drug regimens.Â
There is not any doubt that the approvals will expand the reach of each treatments to 1000’s of eligible patients. Latest cases of multiple myeloma crop up every year: Greater than 35,000 recent cases shall be diagnosed in 2024 within the U.S., in accordance with J&J’s estimates.Â
But the brand new approvals also give J&J’s therapy, which was developed with Legend Biotech, a transparent advantage over Bristol Myers’s drug.Â
The FDA’s expanded approval says patients can use Carvykti after only one prior line of therapy for multiple myeloma and if certain conditions apply. J&J has said that earlier access to the drug may provide patients with the potential for a treatment-free period earlier within the progression of the disease.
Bristol Myers’s Abecma, which is co-marketed by 2seventy bio, might be administered after not less than two drug regimens for multiple myeloma, under the brand new FDA approval.Â
The Latest York Stock Exchange welcomes Bristol Myers Squibb on Nov. twentieth, 2020.
NYSE
Here’s what some analysts are saying: The product label difference between the 2 drugs offers a “significant industrial advantage for Carvykti,” Jefferies analyst Kelly Shi wrote in a Sunday note.Â
Carvykti’s eligibility as a second-line treatment for multiple myeloma “should limit the use” of other similar cell therapies in the next lines of therapy, Shi said.Â
Each Carvykti and Abecma belong to a category of personalized treatments often known as chimeric antigen receptor T-cell – or CAR-T – therapies that work by modifying white blood cells often known as T-cells to attack cancer. J&J’s drug has regularly gained ground over Abecma within the CAR-T marketplace for multiple myeloma, although it first entered the market a yr later.Â
With the brand new approval on Friday, Jefferies’ Shi expects J&J’s drug to win nearly all of that market share. The firm believes Carvykti is “well positioned” to eventually reach greater than 80,000 patients within the U.S., EU and Japan as a second, third or fourth line of therapy.Â
The FDA’s expanded approval of Carvykti could also put it heading in the right direction to be a blockbuster product for J&J. Last yr, the drug pulled in only $500 million in worldwide sales, in accordance with Legend Biotech.Â
The drug’s long-term opportunity might be around $8 billion a yr, 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.Â
Guggenheim analyst Kelsey Goodwin said Abecma’s peak annual sales might be around $450 million a yr, in accordance with a Reuters interview last week. Bristol Myers’s drug brought in $472 million in worldwide sales in 2023.Â
But even with recent approvals under their belts, the 2 corporations are grappling with the identical long-term issue: supply constraints.Â
Each J&J and Bristol Myers have outlined plans to spice up production of their respective drugs. I will be watching to see how that a part of the story plays out later this yr, so stay tuned.
Be at liberty to send any suggestions, suggestions, story ideas and data to Annika at annikakim.constantino@nbcuni.com.
Latest in health care technology
A take a look at Mount Sinai’s approach to AI
Signage hangs outside Mount Sinai Hospital on August 4, 2014 in Latest York City.
Getty Images
On Monday, I visited a part of the Mount Sinai Health System, which spans eight hospital campuses and a medical school, to find out about the way it’s using generative artificial intelligence.Â
In a small corner of The Mount Sinai Hospital that currently serves because the med school’s AI department, I spoke with executives about current initiatives and plans for the long run – including plans to maneuver that very department to a much larger, brand recent constructing 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 top of 2022.
Dr. Bruce Darrow, the health system’s interim chief digital and data officer, said Mount Sinai is evaluating use cases across patient care, education and research. Inside patient care, anything the health system can do to soundly help clinicians and staff speed up decision making is significant, he said.Â
As an illustration, Mount Sinai’s radiologists (doctors who use medical images like CT scans, MRIs and X-rays to discover and treat conditions) are already working with a lot of recent AI tools. Dr. Laurie Margolies, director of breast imaging at Mount Sinai, said she is exposed to a few different AI software tools in her day-to-day work.Â
One tool can evaluate a complete mammogram, one other can evaluate a breast ultrasound and the third evaluates image quality, which radiologists can use to envision on their technique and positioning, Margolies said. While radiologists don’t ever just defer to the pc, she said, AI can assist provide an additional layer of assurance.  Â
“I believe it is a wellness tool,” Margolies said. “I believe it’s making me far more relaxed. When I believe a mammogram is normal, and the AI thinks it’s normal, I’m more confident hitting that standard button.”
Despite the continued hype and excitement around generative AI’s potential in health care, Mount Sinai is attempting to take a measured approach to its implementation. Dr. David Reich, president at The Mount Sinai Hospital and Mount Sinai Queens, said loads of the initial use cases have been reasonably quiet.Â
Certainly one of the primary places the technology was introduced, for example, was in Mount Sinai’s financial departments, where Reich said people are actually processing bills more effectively.Â
“We might reasonably be a bit of bit more slow and plodding and workflow-focused because we’re in a really serious business,” he said.Â
Reich said it may well be difficult to find out which AI solutions are literally worthwhile, so Mount Sinai has established a governance structure to assist assess whether a tool is protected, feasible, practical and ethical to make use of. Above all else, the software needs to assist address real problems, he said.Â
“Plenty of people just need to sell an algorithm,” Reich said.
Be at liberty to send any suggestions, suggestions, story ideas and data to Ashley at ashley.capoot@nbcuni.com.
