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

FDA approves RIABNI™ (rituximab-arrx), a biosimila…

Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved RIABNI™ (rituximab-arrx), a biosimilar to Rituxan®, in combination with ...

Positive Phase 1 data from mRNA-based individualiz…

BioNTech SE (Nasdaq: BNTX, "BioNTech") announced initial data from an ongoing investigator-initiated first-in-human Phase 1 study evaluating the safety and tolerability o...

Sandoz announces new global 'Act4Biosimilars' init…

Sandoz, a global leader in generic and biosimilar medicines, announced the launch of a new global initiative called 'Act4Biosimilars' to help address health inequity and ...

Pfizer to invest $120 million to produce COVID-19 …

Pfizer Inc. (NYSE: PFE) announced today that it will further strengthen its commitment to United States manufacturing with a $120 million investment at its Kalamazoo, Mic...

Proteomic study of 2,002 tumors identifies 11 pan-…

A new study that analyzed protein levels in 2,002 primary tumors from 14 tissue-based cancer types identified 11 distinct molecular subtypes, providing systematic knowled...

Sanoff offers perspective on a promising rectal ca…

UNC Lineberger Comprehensive Cancer Center's Hanna K. Sanoff, MD, MPH, is the author of a viewpoint in the New England Journal of Medicine that provides a perspective on ...

A new technology offers treatment for HIV infectio…

A new study from Tel Aviv University offers a new and unique treatment for AIDS which may be developed into a vaccine or a one time treatment for patients with HIV. The s...

Boehringer Ingelheim signs option to acquire Truti…

Boehringer Ingelheim announced the signing of an option to acquire Trutino Biosciences Inc. (the "Transaction"), a San Diego-based biotech company. Trutino Biosciences...

Broadly neutralizing antibodies could provide immu…

Two broadly neutralizing antibodies show great promise to provide long-acting immunity against COVID-19 in immunocompromised populations according to a paper published Ju...

Novel drug combo activates natural killer cell imm…

Most skin cancer drugs that activate the immune system work by triggering immune cells, called T cells, to attack tumors, but when T cells are activated for too long, the...

Novartis announces Nature Medicine publication of …

Novartis announced that Nature Medicine published final results from both the two- and three-copy cohorts of the completed Phase 3 SPR1NT trial as separate companion manu...

COVID-19 rebound after taking Paxlovid likely due …

Paxlovid is the leading oral medication for preventing severe cases of COVID-19 in high-risk individuals. However, symptoms returned in some patients after treatment was ...