FDA Approves Tecelra as First Gene Therapy for Synovial Sarcoma

Follow Drugslib on

Medically reviewed by Drugs.com.

By Lori Solomon HealthDay Reporter

TUESDAY, Aug. 6, 2024 -- The U.S. Food and Drug Administration has approved Tecelra (afamitresgene autoleucel), a gene therapy for the treatment of adults with unresectable or metastatic synovial sarcoma.

Specifically, the approval is for adults who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive, and have a tumor that expresses the MAGE-A4 antigen. The single-dose, intravenous T-cell immunotherapy is composed of a patient's own T-cells.

The approval was based on an open-label clinical trial of 44 patients with inoperable and metastatic synovial sarcoma. The overall response rate was 43.2 percent, and the median duration of response was six months. The most common adverse reactions seen with Tecelra included nausea, vomiting, fatigue, infections, fever, constipation, dyspnea, abdominal pain, noncardiac chest pain, decreased appetite, tachycardia, back pain, hypotension, diarrhea, and edema.

"Adults with metastatic synovial sarcoma, a life-threatening form of cancer, often face limited treatment options in addition to the risk of cancer spread or recurrence," Nicole Verdun, M.D., director of the Office of Therapeutic Products in the FDA Center for Biologics Evaluation and Research, said in a statement. "Today's approval represents a significant milestone in the development of an innovative, safe, and effective therapy for patients with this rare but potentially fatal disease."

The approval of Tecelra was granted to Adaptimmune.

More Information

Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

Source: HealthDay

Posted : 2024-08-07 07:15

Read more

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Popular Keywords