‘Major step forward’ for adult patients as new blood cancer drug receives FDA approval
The U.S. Food and Drug Administration (FDA) has granted accelerated approval for Talvey, a new antibody-based remedy for adult patients with tough-to-treat blood cancers such as a number of myeloma. The drug is made by Johnson & Johnson.
This is a “major step forward” for the myeloma subject, based on Dr. Ola Landgren, M.D., PhD, chief of the Myeloma Program at Sylvester Comprehensive Cancer Center on the University of Miami Miller School of Medicine.
“This is the first myeloma drug designed to target the protein called GPRC5D, which is expressed on the surface of myeloma cells,” Landgren instructed Fox News Digital.
“It is a new mechanism of action.”
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The FDA grants “accelerated approval” to enable earlier availability of medications that treat serious conditions, according to its website.
Given the “huge unmet clinical need,” Landgren said there is an ongoing need to continue developing safe, effective drugs to target the disease.
For patients just starting on the new drug, Talvey, the first few doses are given in the hospital because there is an early risk of low-grade fever and immunological reactions. The drug has been approved as a weekly or biweekly injection administered by physicians. (iStock)
“This drug is an example of that important momentum,” he said.
Talvey (talquetamab) is intended for multiple myeloma patients who have received at least four prior types of treatment and have a “poor prognosis,” per a press release from Johnson & Johnson.
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The drug has been authorized as a weekly or biweekly injection administered by physicians.
In scientific research, Talvey confirmed “impressive response rates” in myeloma patients who had acquired prior therapies, mentioned Landgren, who’s a famend hematologist/oncologist specializing in a number of myeloma, smoldering myeloma and associated plasma cell problems.
“If everything is done correctly, these drugs are overall very safe and effective.”
“The overall response rate is 70% in patients who failed four prior lines of myeloma therapy,” he mentioned.
“A major clinical issue is that the myeloma tumor cells eventually develop resistance to our therapies,” he went on. “For patients who fail several lines of therapy, eventually, there may not be many treatment options left.”
Risks and limitations
Because it’s an immunotherapy drug, Talvey has the potential to trigger immunosuppression, which can result in an elevated threat of infections, Landgren warned.
The most typical antagonistic results included an altered or impaired sense of style, dry mouth and problem swallowing.
Some patients additionally skilled weight reduction, pores and skin reactions, severe infections, low white blood cell depend and low blood platelets, per the press launch.
The FDA has granted accelerated approval for Johnson & Johnson’s new drug, Talvey, an antibody-based remedy for adult patients with tough-to-treat blood cancers like a number of myeloma. (iStock)
“Trained health care providers know what to look for clinically and how to do lab work to monitor the individual patient’s immune status,” Landgren instructed Fox News Digital. “If everything is done correctly, these drugs are overall very safe and effective.”
For patients simply beginning on the drug, the primary few doses are given within the hospital as a result of there’s an early threat of low-grade fever and immunological reactions, though Landgren mentioned these signs are manageable and normally resolve rapidly.
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“Ongoing studies are seeking to define optimal ways to pre-medicate patients for the first few doses to limit side effects such as fever and immunological reactions, so these drugs can be given outpatient from day one,” he mentioned.
“We are not yet there, but I think we are moving in this direction.”
‘The future is bright’
With the big variety of new, efficient and protected medication, Landgren mentioned “the future is bright” for patients with a number of myeloma.
“We are moving from chemotherapy to immunotherapies,” he mentioned. “We are able to achieve high rates of no detectable disease (called minimal residual disease-MRD-negativity) in myeloma patients.”
Overall survival for patients with myeloma is bettering yearly, a physician instructed Fox News Digital. (iStock)
In one other mark of progress, total survival for patients with myeloma is bettering yearly, the physician famous.
“When I was in fellowship, overall survival for myeloma was one to two years — these days, we are talking 10 to 20 years or longer,” Landgren mentioned.
“We still need to develop curative therapies,” he mentioned. “We (at Sylvester) and other groups are working on that.”
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Given that myeloma is taken into account a uncommon cancer — affecting 35,000 patients yearly within the U.S. — the physician famous {that a} key facet is for patients to have entry to specialised care.
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A myeloma specialist can overview the affected person’s particular person case, develop an optimum therapy plan and optimize the particular person’s prognosis and high quality of life, he mentioned.
