MedPath

FDA Approves Novel Therapies for Synovial Sarcoma, Cutaneous T-Cell Lymphoma, and Subcutaneous Atezolizumab

  • The FDA granted accelerated approval to Tecelra (afamitresgene autoleucel), a T-cell receptor therapy, for inoperable or metastatic synovial sarcoma, marking the first TCR therapy for solid tumors.
  • Lymphir (denileukin diftitox), a novel immunotherapy targeting the IL-2 receptor on malignant T cells, received FDA approval for relapsed or refractory cutaneous T-cell lymphoma.
  • A new subcutaneous injectable formulation of Tecentriq (atezolizumab) was approved, offering a faster, more convenient administration option with comparable efficacy and safety to IV infusions.
The U.S. Food and Drug Administration (FDA) has recently approved several new cancer treatments, offering hope for patients with various malignancies. These approvals include a novel T-cell receptor (TCR) therapy for synovial sarcoma, a new immunotherapy for cutaneous T-cell lymphoma, and a subcutaneous formulation of atezolizumab.

Tecelra Approved for Synovial Sarcoma

Tecelra (afamitresgene autoleucel), a gene therapy, received accelerated approval for patients with inoperable or metastatic synovial sarcoma. This therapy is the first TCR therapy approved for a solid tumor. Tecelra involves genetically modifying a patient's own T cells to express a TCR that targets MAGE-A4, an antigen present on cancer cells. The Phase II SPEARHEAD-1 trial demonstrated an overall response rate of 43%, with 39% of responders still showing benefit at one year.

Lymphir Approved for Cutaneous T-Cell Lymphoma

Lymphir (denileukin diftitox), a recombinant protein, has been approved for relapsed or refractory cutaneous T-cell lymphoma, a rare form of non-Hodgkin lymphoma. Lymphir targets the IL-2 receptor on malignant T cells and delivers a diphtheria toxin to induce cell death. A Phase III study showed an overall response rate of 36%, with approximately half of responders experiencing durable responses lasting at least six months.

Subcutaneous Atezolizumab Approved

The FDA also approved a subcutaneous injectable formulation of Tecentriq (atezolizumab), providing an alternative to intravenous (IV) infusions. This new formulation, administered via subcutaneous injection in the thigh, reduces treatment time to approximately seven minutes, compared to up to an hour for IV infusions. A study in lung cancer patients demonstrated similar overall response rates, overall survival, progression-free survival, and safety profiles between the injectable and IV formulations. Notably, about 70% of patients preferred the injectable version, citing increased comfort and reduced emotional distress.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

FDA Approves Citius Pharmaceuticals' Lymphir for CTCL Treatment

The FDA has approved Citius Pharmaceuticals' Lymphir, a reformulated version of a previously withdrawn lymphoma therapy, for the treatment of relapsed or refractory cutaneous T-cell lymphoma (CTCL). This marks a significant advancement for patients with this rare form of non-Hodgkin lymphoma, offering a new treatment option with the potential to rapidly reduce skin disease and control symptomatic itching without cumulative toxicity.

uniQure Receives FDA Nod for Accelerated Approval Pathway for Huntington's Disease Gene Therapy

uniQure secured FDA agreement to pursue accelerated approval for its Huntington's disease gene therapy, potentially expediting treatment availability.

FDA Approves Tecelra, a TCR-T Cell Therapy, Transforming Solid Tumor Treatment for Synovial Sarcoma

The FDA has approved Tecelra, a TCR-T cell therapy developed by Adaptimmune Therapeutics, marking the first TCR therapy for solid tumors, specifically unresectable or metastatic synovial sarcoma.

FDA Approves Subcutaneous Tecentriq Hybreza for Multiple Cancer Types

The FDA has approved Tecentriq Hybreza, a subcutaneous formulation of atezolizumab, for various cancer indications, offering a new administration route.

FDA Approves Roche's Tecentriq Hybreza, a Subcutaneous PD-L1 Inhibitor, for Multiple Cancers

The FDA has approved Roche's Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), a subcutaneous formulation, for multiple cancer types previously approved for the IV form.

FDA Approves Roche's Tecentriq Hybreza, a Subcutaneous Anti-PD-(L)1 Cancer Immunotherapy

The FDA has approved Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) as the first subcutaneous PD-(L)1 inhibitor for cancer immunotherapy.

FDA Approves Lymphir (denileukin diftitox-cxdl) for Relapsed/Refractory Cutaneous T-Cell Lymphoma

The FDA has approved Lymphir (denileukin diftitox-cxdl) for treating relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

FDA Approves First Bispecific T-Cell Engager for Solid Tumors and Expands Indications for Immunotherapies

The FDA granted accelerated approval to tarlatamab (Imdelltra), the first bispecific T-cell engager for extensive-stage small cell lung cancer (ES-SCLC) that has progressed after chemotherapy.

FDA Approves Tepylute, a Ready-to-Dilute Thiotepa Formulation, for Breast and Ovarian Cancer

The FDA has approved Tepylute, a ready-to-dilute formulation of thiotepa, for treating breast and ovarian cancer, addressing limitations of the previous powder form.

FDA Approves Lifileucel (Amtagvi): First TIL Therapy for Melanoma

The FDA has granted accelerated approval to lifileucel (Amtagvi) for advanced melanoma after prior therapies, marking the first tumor-infiltrating lymphocyte (TIL) therapy approval.

Reference News

[1]
FDA Approves New Cancer Treatments
cancerhealth.com · Dec 9, 2024

FDA granted accelerated approval to Tecelra, the first T-cell receptor therapy for solid tumors, and Lymphir for cutaneo...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy