This section highlights FDA-related milestones and regulatory updates for drugs developed by Adaptimmune Therapeutics (ADAP).
Over the past two years, Adaptimmune Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Afamitresgene and lete-cel. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Afamitresgene autoleucel (afami-cel, formerly ADP-A2M4) - FDA Regulatory Timeline and Events
Afamitresgene autoleucel (afami-cel, formerly ADP-A2M4) is a drug developed by Adaptimmune Therapeutics for the following indication: Advanced synovial sarcoma or MRCLS.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Afamitresgene autoleucel (afami-cel, formerly ADP-A2M4)
- Announced Date:
- December 2, 2024
- Indication:
- Advanced synovial sarcoma or MRCLS
Announcement
Adaptimmune Therapeutics plc announced that the first patient has been treated with TECELRA® (afamitresgene autoleucel).
AI Summary
Adaptimmune Therapeutics plc has reached a key milestone by treating its first patient with TECELRA® (afamitresgene autoleucel). This innovative engineered cell therapy offers a new treatment option for adults suffering from synovial sarcoma—a rare and aggressive form of soft tissue cancer that mostly affects young adults. The patient was treated at Moffitt Cancer Center, one of the company’s Authorized Treatment Centers, which is known for its expertise in sarcoma care.
TECELRA® is unique as it is the first engineered cell therapy approved in the U.S. for a solid tumor cancer. This one-time infusion treatment aims to improve outcomes for patients who have previously undergone chemotherapy. Adaptimmune is committed to expanding access to TECELRA®, with plans for a broad network of treatment centers across the U.S. by the end of 2025.
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lete-cel - FDA Regulatory Timeline and Events
lete-cel is a drug developed by Adaptimmune Therapeutics for the following indication: For Myxoid/Round Cell Liposarcoma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- lete-cel
- Announced Date:
- January 13, 2025
- Indication:
- For Myxoid/Round Cell Liposarcoma
Announcement
Adaptimmune Therapeutics plc announced that letetresgene autoleucel (lete-cel), has been granted breakthrough therapy designation by the U.S. FDA for the treatment of patients with unresectable or metastatic myxoid/round cell liposarcoma (MRCLS) who have received prior anthracycline-based chemotherapy, are positive for HLA-A*02:01, HLA-A*02:05, or HLA-A*02:06, and whose tumor expresses the NY-ESO-1 antigen.
AI Summary
Adaptimmune Therapeutics plc announced that its cell therapy, letetresgene autoleucel (lete-cel), has received breakthrough therapy designation from the U.S. FDA. This designation is for treating patients with unresectable or metastatic myxoid/round cell liposarcoma (MRCLS) who have already received anthracycline-based chemotherapy. To be eligible, patients must test positive for HLA-A*02:01, HLA-A*02:05, or HLA-A*02:06, and their tumors must express the NY-ESO-1 antigen.
The breakthrough therapy designation is based on promising results from the Phase II IGNYTE-ESO trial. It is expected to speed up the development and review process by allowing additional FDA guidance, rolling submissions, and potential priority review. This move underscores the potential of lete-cel to address an important unmet need in MRCLS treatment by improving key clinical outcomes and offering a new option for patients who have already undergone chemotherapy.
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