FDA Approves First Drug to Improve Overall Survival in Liposarcoma

Regulatory NewsRegulatory News
| 28 January 2016 | By Michael Mezher 

The US Food and Drug Administration (FDA) on Thursday approved a new indication for Eisai's Halaven (eribulin mesylate) to treat liposarcoma, a rare and deadly form of soft tissue sarcoma (STS) that affects only a few thousand patients in the US each year.

FDA said Halaven is approved to treat liposarcoma that cannot be operated on, or has metastasized in patients who have already undergone chemotherapy.

"Halaven is the first drug approved for patients with liposarcoma that has demonstrated an improvement in survival time," said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products at the Center for Drug Evaluation and Research, calling the improvement "clinically meaningful."

Halaven was first approved by FDA in 2010 to treat late-stage breast cancer after the drug demonstrated an improvement in overall survival compared to other single agent therapies.

The drug was approved based on data from a Phase III study that compared Halaven to dacarbazine, a chemotherapy agent commonly used to treat STS either in monotherapy or in combination with other drugs. Halaven was granted both priority review and orphan drug designation due to the rarity and serious nature of liposarcoma.

According to FDA, data from the study showed patients treated with Halaven had a median overall survival of 15.6 months, compared to 8.4 months for those in the comparator arm.

While Halaven is the first drug approved by FDA to demonstrate an improvement in overall survival in liposarcoma, the drug did not demonstrate an improvement in progression-free survival. FDA recently approved another drug, Janssen's Yondelis, for liposarcoma after it demonstrated an improvement in progression-free survival without demonstrating benefit in overall survival.

While there have been significant advances is available treatments for cancer in recent years, the price of these drugs has often come under fire.

According to MedScape, the average wholesale price of Halaven is $1037 per 1-mg vial, and based on dosing guidelines patients will likely require three vials per dose, given twice per 21-day cycle.



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