Eribulin Mesylate (Halaven): First drug to show survival benefit in unresectable or metastatic liposarcoma

January 28, 2016 – Soft tissue sarcoma (STS) is a disease in which cancer cells form in the soft tissues of the body, including the muscles, tendons, fat, blood vessels, lymph vessels, nerves and tissues around joints. Liposarcoma is a specific type of STS that occurs in fat cells. STS can form almost anywhere in the body, but is most common in the head, neck, arms, legs, trunk and abdomen. In 2014, an estimated 12,000 cases of STS were diagnosed in the United States, according to the National Cancer Institute.

The American Food and Drug Administration just approved Eribulin Mesylate (Halaven), a type of chemotherapy, for the treatment of liposarcoma that cannot be removed by surgery (unresectable) or is advanced (metastatic). This treatment is approved for patients who received prior chemotherapy that contained an

Eribulin Mesylate (Halaven)

Eribulin Mesylate (Halaven)

anthracycline drug. According to Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, Eribulin Mesylate (Halaven) is the first drug approved for patients with liposarcoma that has demonstrated an improvement in survival time, i.e., this is a new indication for this drug. Previously, Eribulin Mesylate (Halaven) had been approved by the FDA in 2010 to treat patients with metastatic breast cancer who had received at least two prior chemotherapy regimens for late-stage disease, including both anthracycline– and taxane-based chemotherapies. It was also approved by Health Canada and the EMA (European Union) in 2011 for treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease.

Here, the efficacy of Eribulin Mesylate (Halaven) was evaluated in 143 clinical trial participants with advanced liposarcoma that was unresectable or had spread to nearby lymph nodes (locally advanced) or other parts of the body (metastatic), and who had been treated with chemotherapy. Participants were treated with either Eribulin Mesylate (Halaven) or another chemotherapy drug called dacarbazine until their disease spread or until they were no longer able to tolerate the side effects of treatment. The study was designed to measure the length of time from the start of treatment until a patient’s death (overall survival). The median overall survival for patients with liposarcoma receiving Eribulin Mesylate (Halaven) was 15.6 months compared to 8.4 months for those who received dacarbazine.

The most common side effects among participants treated with Eribulin Mesylate (Halaven) were fatigue, nausea, hair loss (alopecia), constipation, certain nerve damage causing weakness or numbness in the hands and feet (peripheral neuropathy), abdominal pain and fever (pyrexia). Eribulin Mesylate (Halaven) may also cause decreased levels of potassium or calcium. Serious side effects from treatment with Halaven may include a decrease in white blood cell count (neutropenia), which can increase the risk of serious infections that could lead to death; numbness, tingling or burning in the hands and feet (peripheral neuropathy); harm to a developing fetus; as well as changes in heartbeat (QTc prolongation), that may also lead to death.

Follow also this message on liposarcoma:

 
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Ph.D.; Professor in Pharmacology and Toxicology. Senior expert in theragenomic and personalized medicine and individualized drug safety. Senior expert in pharmaco- and toxicogenetics. Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.

Posted in New Indication Approval, Thasso Post, Theragenomic Medicine
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