FDA Approves Trabectedin for Sarcoma

FDA Approves Trabectedin for Sarcoma - NCI

The FDA has approved trabectedin for patients with advanced liposarcoma and leiomyosarcoma whose cancer has progressed after prior ...

FDA Approval Summary: Trabectedin for Unresectable or Metastatic ...

On October 23, 2015, the FDA approved trabectedin, a new molecular entity for the treatment of patients with unresectable or metastatic ...

U.S. FDA Approves YONDELIS® (trabectedin) for the Treatment of ...

today announced the U.S. Food and Drug Administration (FDA) has approved YONDELIS® (trabectedin) for the treatment of patients with unresectable ...

Yondelis (trabectedin) FDA Approval History - Drugs.com

Yondelis FDA Approval History ... Yondelis (trabectedin) is a cytotoxic antitumor agent for the treatment of unresectable or metastatic liposarcoma or ...

FDA Approval Summary: Trabectedin for Unresectable or Metastatic ...

The FDA granted orphan drug designation for trabectedin for the treatment of STS in 2004. On November 24, 2014, Janssen submitted an NDA for trabectedin for ...

New Therapeutic for Treating Certain Soft Tissue Sarcomas

The FDA has approved trabectedin for the treatment of certain patients with two types of soft tissue sarcoma, liposarcoma and leiomyosarcoma.

YONDELIS (trabectedin) for injection, for intravenous use

tissue sarcoma receiving YONDELIS were: Nervous ... Advise the patient to read the FDA-approved patient labeling (Patient Information).

Yondelis (Trabectedin) Approved for the Treatment of Unresectable ...

On October 23, 2015, trabectedin (Yondelis; Janssen), an alkylating drug, was approved by the FDA for the treatment of patients with unresectable or metastatic ...

FDA Approves New Therapeutic for Treating Certain Soft Tissue ...

Specifically, trabectedin is approved for treating patients with liposarcoma and leiomyosarcoma that cannot be removed by surgery or that is ...

FDA Approves Trabectedin for Certain Types of Advanced Soft ...

On 23 October, 2015 the US Food and Drug Administration (FDA) approved trabectedin (Yondelis) for the treatment of two types of soft tissue ...

Trabectedin for Soft Tissue Sarcoma: Current Status and Future ...

Approval was based on the results of a pivotal Phase 3 trial involving a 2:1 randomization of 518 patients (who were further stratified by soft tissue sarcoma ...

Yondelis PAC Review 2023 FINAL - FDA

Trabectedin is an alkylating drug, initially approved in the U.S. on October 23, 2015. ... osteosarcoma, Ewing sarcoma, and non-rhabdomyosarcoma ...

FDA Approves Trabectedin in Soft Tissue Sarcoma

The FDA has approved trabectedin (Yondelis) for the treatment of patients with unresectable or metastatic soft tissue sarcoma who have previously received ...

Yondelis® Approved for Treatment of Soft Tissue Sarcoma

The United States Food and Drug Administration (FDA) approved the chemotherapy agent, Yondelis® (trabectedin), for the treatment of liposarcoma and ...

FDA Approves Trabectedin (Yondelis) for Advanced Soft-Tissue ...

Trabectedin was first approved in Europe in 2007, and is indicated there for both soft-tissue sarcoma and for ovarian cancer. “Since Yondelis ...

FDA Approves Trabectedin for Advanced Liposarcoma and ...

The U.S. Food and Drug Administration has approved the novel chemotherapy drug trabectedin (Yondelis) for the treatment of specific ...

FDA Approves Trabectedin in Soft Tissue Sarcomas - OncLive

The FDA has approved trabectedin (Yondelis) for the treatment of patients with unresectable or metastatic soft tissue sarcoma—specfically, ...

FDA approves Yondelis for treatment of specific unresectable or ...

The FDA approved the chemotherapeutic agent trabectedin to treat liposarcoma and leiomyosarcomas — soft tissue sarcomas that are difficult ...

FDA approves trabectedin for some advanced soft tissue sarcomas

The Food and Drug Administration has approved trabectedin for the treatment of advanced or unresectable liposarcomas and leiomyosarcomas ...

FDA Approves New Therapy for Certain Types of Advanced Soft ...

The US Food and Drug Administration (FDA) today approved Yondelis (trabectedin), a chemotherapy, for the treatment of specific soft tissue ...