FDA

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

Ready. Raise. Rise. Campaign

The Ready. Raise. Rise. campaign encourages everyone to raise and share a flag to salute those who have been touched by cancer, especially patients and caregivers, and le...

Read more

Pfizer reports first-quarter 2016 r…

Pfizer Inc. (NYSE: PFE) reported financial results for first-quarter 2016 and updated certain components of its 2016 financial guidance. Reported revenues totaled $13.0 b...

Read more

AstraZeneca completes acquisition o…

AstraZeneca has completed the acquisition of the core respiratory business of Takeda Pharmaceutical Company Limited ("Takeda"). The agreement, announced in December 2015...

Read more

Research points to a new treatment …

Researchers have shown how controlling cholesterol metabolism in pancreatic cancer cells reduces metastasis, pointing to a potential new treatment using drugs previously ...

Read more

Grants4Apps Accelerator 2016: You i…

The Grants4Apps (G4A) Accelerator developed by Bayer invites health IT and technology startups to apply for the program's 2016 edition. This year, Bayer looks primarily i...

Read more

Pfizer awards more than $1 million …

Pfizer Inc. (NYSE:PFE) has awarded a total of more than $1 million in funding to five leading breast cancer advocacy organizations to support projects focused on metastat...

Read more

Selumetinib granted Orphan Drug Des…

AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation for the investigational MEK 1/2 inhibitor, selumetinib (AZD...

Read more

Why are women less likely to be pre…

Statins are equally effective at decreasing risk of coronary events in men and women, and yet women are less likely to be prescribed these cholesterol-lowering drugs than...

Read more

Bengt Sjöberg donates SEK 2 billion…

Bengt Sjöberg, resident in Hong Kong but originally from Lysekil, Sweden, has founded the Sjöberg Foundation, to which he has donated SEK 2 billion. His hope is that this...

Read more

A faster and cheaper way to produce…

A novel way of synthesising a promising new antibiotic has been identified by scientists at the University of Bristol. By expressing the genes involved in the production ...

Read more

UCB, Teva, Novartis, Pfizer and Tra…

2 - 3 May 2016, Philadelphia, USA. The 2016 eyeforpharma Philadelphia Awards saw 22 finalists, with representation from every top 20 pharma, showcase the breadth of in...

Read more

New microbiome research tool offers…

The University of Luxembourg today announced the publication of a research article in the internationally renowned scientific journal Nature Communications. The article i...

Read more

Digest World Pharma Newsletter

Subscribe to our weekly Digest World Pharma Newsletter and stay updated on the latest World Pharma News. Subscribe now, it's free!

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 ]