US WorldMeds® Receives Full U.S. FDA Approval of TECELRA® (afamitresgene autoleucel) with an Expanded Indication, Extending the First Approved Engineered T-Cell Therapy for a Solid Tumor to Children as Young as 12

Eligibility extends to patients with unresectable or metastatic synovial sarcoma who have received prior chemotherapy and meet HLA and MAGE-A4 eligibility criteria

LOUISVILLE, Ky., June 22, 2026 /PRNewswire/ -- USWM CT, LLC (US WorldMeds) announced that the U.S. Food and Drug Administration (FDA) has granted full approval of TECELRA^® (afamitresgene autoleucel) and expanded its indication to include pediatric patients 12 years of age and older with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices. Administered as a single infusion, TECELRA became the first engineered T-cell therapy for a solid tumor cancer to receive accelerated FDA approval in the United States, granted in August 2024.

"Today's approval marks an important milestone not only for US WorldMeds, but for the synovial sarcoma community," said Breck Jones Sr., Founder and CEO of US WorldMeds. "With the transition to full approval, TECELRA continues to represent an important treatment option for appropriate patients with biomarker-eligible, advanced synovial sarcoma. This approval is supported by additional clinical evidence which may provide physicians, patients, and families with confidence as they consider treatment decisions. The expansion to include patients as young as 12 years old further broadens access to this personalized approach."

"What sets TECELRA apart is that it is personalized to each individual, engineering a patient's own T-cells to detect, target, and attack their cancer. Until today, that option was only available to adults," said Kristen Gullo, Senior Vice President of US WorldMeds. "For patients 12 years of age and older with biomarker-eligible, advanced synovial sarcoma, today's decision opens the door to a new treatment approach that was previously out of reach and offers hope where options have been extremely limited."

The full FDA approval and expanded indication for TECELRA was based on results of the SPEARHEAD-1 study (Cohorts 1, 2 and 3), an open-label, single-arm clinical study, which included 137 patients. The primary efficacy outcome was overall response rate (ORR) determined by independent review and supported by duration of response. TECELRA treatment resulted in an ORR of 43.8% with a complete response rate of 3.6%. The median duration of response was 5.3 months (95% CI: 4.5, 8.2). Among patients who were responsive to the treatment, 31.9% had a duration of response of 24 months or longer.*

"For children as young as 12 with advanced synovial sarcoma, treatment options have been limited and navigating care decisions can be challenging," said Amy Armstrong, MD, Associate Professor of Pediatrics at Washington University School of Medicine in St. Louis and Director of the Solid Tumor Program at Siteman Kids at St. Louis Children's Hospital. "The availability of an engineered cell therapy for adolescents introduces an important new option for patients who are biomarker-eligible, allowing us to incorporate this approach into treatment planning based on the same evidence that has guided adult care. This is a meaningful step forward for the field."

For more information about TECELRA visit www.TECELRA.com.

About Synovial Sarcoma
There are more than 50 different types of soft tissue sarcomas which can arise in fat, muscle, nerves, fibrous tissues, blood vessels, or deep skin tissues.¹ Synovial sarcoma accounts for approximately 5 to 10% of all soft tissue sarcomas (there are approximately 13,400 new soft tissue sarcoma cases in the U.S. each year).^1,2 Approximately one-third of patients with synovial sarcoma are diagnosed under the age of 30.² The five-year survival rate for people with metastatic disease is approximately 20% and recurrence is common in advanced disease.^1,3

About TECELRA
TECELRA (afamitresgene autoleucel) is a genetically modified autologous T cell immunotherapy indicated for adult and pediatric patients 12 years of age and older with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A02:01P, -A02:02P, -A02:03P, or -A02:06P positive, and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices. TECELRA is made from a patient's own white blood cells that are genetically modified to recognize and attack cancer cells. A healthcare provider will perform tests to see if TECELRA is right for each patient.

IMPORTANT SAFETY INFORMATION
Important Warning: You will likely be in a hospital before and after getting TECELRA. TECELRA may cause side effects that can be severe or life-threatening. Call your healthcare provider or get emergency help right away if you get any of the following: fever (100.4°F/38°C or higher); chills/shivering; difficulty breathing; fast or irregular heartbeat; low blood pressure; fatigue; severe nausea, vomiting, or diarrhea; severe headache; or new skin rash. Tell all your healthcare providers that you were treated with TECELRA.

After getting TECELRA, you will be monitored daily at the healthcare facility for at least 7 days after the infusion. You should plan to stay close to a healthcare facility for at least 2 weeks. Do not drive, operate heavy machinery, or do other activities that could be dangerous for at least 2 weeks after you get TECELRA. Your healthcare provider will do blood tests to follow your progress. It is important that you have your blood tested. If you miss a scheduled appointment for your collection of blood, call your healthcare provider as soon as possible to reschedule.

Before you receive TECELRA, tell your healthcare provider about all the medicines and supplements you take and your medical conditions, including: seizure, stroke, confusion, or memory loss; heart, liver, or kidney problems; low blood pressure; lung or breathing problems; recent or active infection; past infections that can be reactivated following treatment with TECELRA; low blood counts; pregnancy, you think you may be pregnant, or plan to become pregnant; breastfeeding; or taking a blood thinner.

The most common side effects of TECELRA include nausea, fatigue, infection, fever (100.4°F/38°C or higher), constipation, vomiting, headache, diarrhea, fast heart rate, cough, increased aspartate aminotransferase, increased alanine aminotransferase, decreased lymphocyte count, decreased white blood cell count, decreased neutrophil count, decreased red blood cell count, and decreased platelet count.

You are encouraged to report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch or to US WorldMeds at 1-855-246-9232.

Please see full Prescribing Information, including Boxed Warning and Medication Guide.

About US WorldMeds
US WorldMeds is a U.S.-based pharmaceutical company focused on rare and specialty treatments. Our portfolio includes approved therapies for rare diseases and bleeding disorders, including IWILFIN^®, REVONTO^®, and TECELRA^®.

References
¹ "What is a Soft Tissue Sarcoma?" American Cancer Society. https://www.cancer.org/cancer/types/soft-tissue-sarcoma/about/soft-tissue-sarcoma.html. Accessed May 15, 2026.
² "Soft Tissue Sarcoma." Cleveland Clinic. https://my.clevelandclinic.org/health/diseases/21732-soft-tissue-sarcoma. Accessed May 15, 2026.
³ Jami SA, Mobarak SA, Jiandang S, et al. Clinical and strategic outcomes of metastatic synovial sarcoma on limb. Int J Health Sci(Qassim). 2020;14:38–43.
*Per Kaplan-Meier method

Media Contact
Maria Lopes
VP, Marketing & Commercial Operations
USWM CT, LLC
Phone: 1-833-935-6676
Email: [email protected]

SOURCE US WorldMeds