United States – A new immunotherapy has been approved to treat mesothelioma – a rare type of cancer that affects soft tissues and is most often diagnosed in young men.
Tecelra (afamitresgene autoleuecel) has been approved for synovial sarcoma, which is a rare cancer that forms in the soft tissue of muscles and ligaments of the arms and legs by the U. S. Food and Drug Administration through an accelerated procedure, as reported by HealthDay.
A Promising Addition
As stated by the researchers, Tecelra is the first lab-engineered Immune cell therapy that has been approved by the FDA for solid tumor cancer. It was developed by an American pharmaceutical company called Adaptimmune, based in Philadelphia, which contributed to the clinical trials to obtain the approval.
“This treatment will be a promising addition for those diagnosed with this rare type of cancer,” said Dr. Sandra D’Angelo, the lead author of the study, a sarcoma oncology and immunotherapy professional of the Memorial Sloan Kettering Cancer Center in New York City. “It also marks a significant progress in the T-cell therapy of solid tumor which has posed so much a challenge. ”
Need for More Effective Treatments
The FDA said that less than 1,000 Americans are diagnosed with synovial sarcoma each year. It affects predominantly young men; it can start from a man’s thirty or even earlier.
Until now, the management consisted of the surgical removal of the tumor and then the use of radiation or chemotherapy.
”In general, and even with respect to synovial sarcoma in particular, there remains a significant and unmet need for better treatments,” D’Angelo said in a Sloan Kettering news release. “If it is taken to other parts of the body, it is very hostile to manage with therapies in our disposal at the moment. ”
It involves the enrollment of a patient’s T-cells, which are blood cells that are genetically altered to enhance their ability to identify cancer cells for destruction.
Clinical Trial Results Show Promise
The approval was given according to a clinical trial conducted on 52 subjects diagnosed with synovial sarcoma or myxoid/round cell liposarcoma (MRCLS), another STS subtype. This was because none of the patients had responded to other therapies.
Seventeen out of 29 patients had their tumors reduced post-treatment with Tecelra, as revealed in the test results.
In general, the drug was effective in 39% of patients diagnosed with synovial sarcoma and in 25% of those diagnosed with MRCLS.
Improved Survival and Manageable Side Effects
The survival benefits of the therapy for the patients with synovial sarcoma were 11.6 months on average, results show.
“These findings are significant for a group of patients who have largely exhausted other treatment options,” D’Angelo said, as reported by HealthDay.
A Major Step Forward
About 71% of patients reported cytokine release syndrome, which is the immune system over-activation that happens while fighting cancer cells. However, researches added the syndrome was not severe in most patients.
“Adult patients with metastatic synovial sarcoma – a deadly form of cancer, struggle with few therapeutic choices, not to mention the possibility of cancer metastases or relapse,” said Dr. Nicole Verdun, the director of the FDA’s OB Transmission. “Today’s approval has marked a major step forward in the creation of a new kind of therapy for people who suffer from this comparatively rare but potentially lethal illness.