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U.S. FDA Approves YONDELIS®


FDA Approves Trabectedin for Sarcoma - NCI

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

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

The US Food and Drug Administration (FDA) has approved YONDELIS® (trabectedin) for the treatment of patients with unresectable (unable to be removed with ...

Yondelis (trabectedin) FDA Approval History - Drugs.com

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

YONDELIS (trabectedin) for injection, for intravenous use

Initial U.S. Approval: 2015 ... Advise the patient to read the FDA-approved patient labeling (Patient Information).

Yondelis PAC Review 2023 FINAL - FDA

Trabectedin is an alkylating drug, initially approved in the U.S. on October 23, 2015. Trabectedin is currently indicated for the treatment ...

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 ...

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 ...

HCP Efficacy Information - YONDELIS®

YONDELIS® is the first FDA-approved treatment for liposarcoma and ... CI=confidence interval; FDA=US Food and Drug Administration; HR=hazard ratio.

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

The US Food and Drug Administration announced the approval of trabectedin (Yondelis) for the treatment of liposarcoma and leiomyosarcoma ...

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 soft ...

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

On October 23, 2015, the FDA approved trabectedin ... Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, ...

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

The flurry of anticancer therapeutics approved by the U.S. Food and Drug Administration (FDA) late last month included the approval of ...

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 ...

Drug Trials Snapshots: YONDELIS - FDA

YONDELIS is a drug used to treat patients with liposarcoma and leiomyosarcoma that cannot be removed by surgery (unresectable) or is advanced (metastatic).

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 in Soft Tissue Sarcomas - OncLive

The FDA has approved trabectedin for the treatment of patients with advanced soft tissue sarcoma, including liposarcoma and leiomyosarcoma ...

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

The effectiveness and safety of Yondelis were demonstrated in 518 clinical trial participants with metastatic or recurrent leiomyosarcoma or ...

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

PRNewswire/ -- Janssen Biotech, Inc. today announced the U.S. Food and Drug Administration (FDA) has approved YONDELIS® (trabectedin) for ...

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 ...

Search Orphan Drug Designations and Approvals - FDA

Marketing approved: ; 1 ; trabectedin · Yondelis · 10/23/2015 · For the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who ...