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https://www.adaptimmune.com/investors-and-media/...ptimmunes-tecelrar
"First Patient Treated with Adaptimmune's TECELRA(R) (afamitresgene autoleucel)
December 02, 2024 4:00pm EST
Dosing marks a milestone for first engineered cell therapy approved in the U.S. for a solid tumor cancer, synovial sarcoma
Philadelphia, Pennsylvania and Oxford, United Kingdom--(Newsfile Corp. - December 2, 2024) - Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company working to redefine the treatment of solid tumor cancers with cell therapy, today announced that the first patient has been treated with TECELRA® (afamitresgene autoleucel). TECELRA is the first engineered cell therapy for a solid tumor cancer approved in the U.S., and the first new therapy option in more than a decade for synovial sarcoma, a rare, soft tissue cancer that most commonly impacts young adults. The patient was treated at Moffitt Cancer Center, one of Adaptimmune's Authorized Treatment Centers (ATCs) and a leader in sarcoma research and treatment.
In August 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval of TECELRA for the treatment of adults 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. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Adrian Rawcliffe, Adaptimmune's Chief Executive Officer:
"Dosing our first commercial TECELRA patient, in partnership with one of the top cancer centers in the U.S., is an incredible milestone for the sarcoma community and for Adaptimmune. We are focused now on reaching as many eligible synovial sarcoma patients as possible with this one-time infusion treatment as well as advancing our broader sarcoma franchise as we aim to ultimately redefine the way cancer is treated."
Mihaela Druta, MD, Medical Oncologist and Vice Chair of the Sarcoma Department, Sarcoma Medical Oncology at Moffitt Cancer Center; SPEARHEAD-1 Trial Investigator:
"Synovial sarcoma is a particularly devastating type of cancer, affecting many patients in the primes of their lives with poor prognosis for those who fail first-line treatment. Despite this outlook, in the last decade we have seen no new, effective treatments become available to patients. TECELRA's one-time infusion treatment provides a much-needed option to patients with unresectable or metastatic synovial sarcoma, offering a novel therapeutic approach to treatment as well as a new found sense of hope for patients and their loved ones."
Several Authorized Treatment Centers (ATCs) are accepting referrals across the US where patients and healthcare providers can initiate the TECELRA treatment journey. Adaptimmune is confident the full ATC network of approximately 30 ATCs will be active by the end of 2025, covering an estimated 80% of patients treated in sarcoma centers of excellence. Healthcare providers anywhere in the country can get patients tested for the biomarkers. In addition, an integrated support program, AdaptimmuneAssist, is available to enable a seamless and personalized experience through the treatment journey."
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