Eisai grabs an FDA approval for life-extending soft tissue cancer drug
- Eisai's Halaven (eribulin mseylate) has been approved by the FDA for treatment of liposarcoma, a form of soft tissue sarcoma that affects the fat cells.
- This is the first approved drug for liposarcoma to show a survival benefit.
- In a study involving 143 patients with advanced liposarcoma, patients who were treated with Halaven had a median overall survival of 15.6 months, compared with 8.4 months for those who received dacarbazine, which is commonly used to treat liposarcoma.
Halaven, which is already approved for treatment of metastatic breast cancer, has a known safety profile. It may cause neutropenia, predisposing patients to serious infection. The fact that Halaven has been on the market for more than two years is good from a treatment perspective, because there is real-world data available about its safety.
More importantly, Halaven represents a therapeutic breakthrough—the first drug to show a survival benefit in a disease that is difficult to treat. In fact, treatment with Halaven almost doubled median overall survival time.
"Halaven is the first drug approved for patients with liposarcoma that has demonstrated an improvement in survival time," said Dr. Richard Pazdur of the FDA in a statement. "The clinical trial data the FDA reviewed indicates that Halaven increased overall survival by approximately seven months, offering patients a clinically meaningful drug."