FDA approves first drug to show survival benefit in liposarcoma

FDAThe U.S. Food and Drug Administration today approved Halaven (eribulin mesylate), a type of chemotherapy, for the treatment of liposarcoma (a specific type of soft tissue sarcoma) that cannot be removed by surgery (unresectable) or is advanced (metastatic). This treatment is approved for patients who received prior chemotherapy that contained an anthracycline drug.

"Halaven is the first drug approved for patients with liposarcoma that has demonstrated an improvement in survival time," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. "The clinical trial data the FDA reviewed indicates that Halaven increased overall survival by approximately seven months, offering patients a clinically meaningful drug."

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 efficacy and safety of Halaven were 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 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 Halaven was 15.6 months compared to 8.4 months for those who received dacarbazine.

The most common side effects among participants treated with 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). Halaven may also cause low levels of infection-fighting white blood cells (neutropenia) or decreased levels of potassium or calcium.

Serious side effects from treatment with Halaven may include a decrease in white blood cell count, which can increase the risk of serious infections that could lead to death; numbness, tingling or burning in the hands and feet (neuropathy); harm to a developing fetus; as well as changes in heartbeat (QTc prolongation), that may also lead to death.

The FDA granted the Halaven application priority review status, intended to facilitate and expedite the development and review of certain drugs in light of their potential to benefit patients with serious or life-threatening conditions. Halaven also received orphan drug designation, which provides incentives such as tax credits, user fee waivers, and eligibility for exclusivity to assist and encourage the development of drugs for rare diseases.

Halaven is marketed by Eisai based in Woodcliff Lake, New Jersey.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Most Popular Now

Meditation, yoga and vegetarian diet linked to dec…

In a novel controlled clinical trial, participants in a six-day Ayurvedic-based well-being program that featured a vegetarian diet, meditation, yoga and massages experien...

Read more

Abbott to sell Abbott Medical Optics to Johnson …

Abbott (NYSE: ABT) announced today that it will sell Abbott Medical Optics, its vision care business, to Johnson & Johnson for $4.325 billion in cash. Abbott's vision bus...

Read more

Novartis convenes experts to discuss new technolog…

Novartis today opened the 13th International Biotechnology Leadership Camp (BioCamp). Over the course of three days more than 60 selected students from international univ...

Read more

Caffeine and its analogues revert memory deficits …

A study published in the journal Scientific Reports from Nature publishing group, describes the mechanism by which caffeine counteracts age-related cognitive deficits in ...

Read more

Amgen obtains global development and commercial ri…

Amgen (NASDAQ:AMGN) and Boehringer Ingelheim today announced that Amgen has acquired global development and commercial rights from Boehringer Ingelheim for BI 836908 (AMG...

Read more

Vitamin C may boost effectiveness of acute myeloid…

A simple adjustment to patients' therapeutic regimen may improve the effectiveness of the standard epigenetic treatment for myeloid dysplastic syndrome (MDS) and acute my...

Read more

Roche ranked most sustainable healthcare company i…

For the eighth consecutive year, Roche (SIX: RO, ROG; OTCQX: RHHBY) has been recognised as Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life...

Read more

10th European Medical Information and Communicatio…

29 - 30 November 2016, Berlin, Germany The 10th year of the Annual European Medical Information and Communications Conference is a unique meeting organised by medical in...

Read more

Saniona and Boehringer Ingelheim sign collaboratio…

Boehringer Ingelheim, one of the world's 20 leading pharmaceutical companies, and Saniona, a leading biotech company in the field of ion channel drug discovery, have ente...

Read more

Study shows how Chinese medicine kills cancer cell…

Researchers at the University of Adelaide have shown how a complex mix of plant compounds derived from ancient clinical practice in China - a Traditional Chinese Medicine...

Read more

Benralizumab phase III trials show positive result…

Results from pivotal Phase III trials presented at the European Respiratory Society (ERS) International Congress demonstrated that adding benralizumab to standard-of-care...

Read more

Antibody reduces harmful brain amyloid plaques in …

Although the causes of Alzheimer's disease are still unknown, it is clear that the disease commences with progressive amyloid deposition in the brains of affected persons...

Read more

Pharmaceutical Companies

[ A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Z ]