FDA Approves Eribulin for Metastatic Breast Cancer

Oncologists have a new Food and Drug Administration–approved option, eribulin mesylate, for patients with metastatic breast cancer that has stopped responding to at least two chemotherapy regimens for early- or late-stage disease.

An injectable microtubule inhibitor, eribulin is a synthetic version of a compound derived from the sea sponge Halichondria okadai. It will be marketed as Halaven by Eisai Inc., a Japanese-owned company based in Woodcliff Lake, N.J.

Before eribulin is introduced, patients should have been treated with taxane- and anthracycline-based regimens, according to the FDA announcement. The agency skipped review by its Oncologic Drugs Advisory Committee, after the new drug proved superior to other single-drug regimens in a company-sponsored phase III clinical trial presented at the American Society of Clinical Oncology’s annual meeting earlier this year.

"There are limited treatment options for women with aggressive forms of late-stage breast cancer who have already received other therapies," said Dr. Richard Pazdur, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research, in the FDA statement. "Halaven shows a clear survival benefit and is an important new option for women."

In the EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician’s Choice Versus Eribulin) trial, eribulin therapy extended overall survival from 10.65 months in a control arm to 13.12 months (P = .041). Eribulin 1.4 mg/m2 was administered on days 1 and 8 every 21 days.

Women in the control group received single-agent treatments chosen by their physicians. Vinorelbine was the most frequent choice, followed by gemcitabine, capecitabine, taxanes, and anthracyclines, Dr. Christopher Twelves, a professor at the University of Leeds in the United Kingdom, reported at the ASCO meeting. The overall response rate was 12.2% for eribulin vs. 4.7% for physician’s choice, he said.

Dr. Twelves described eribulin’s safety profile as consistent with phase II trial data, showing an increase in grade 3 or 4 neutropenia (21% grade 3, 24% grade 4), febrile neutropenia (3%, 1%), fatigue (8%, 0.6%), and neuropathy (7.8%, 0.4%).

According to the FDA announcement, the most common side effects reported by women treated with eribulin include neutropenia, anemia, leukopenia, alopecia, fatigue, nausea, asthenia, peripheral neuropathy, and constipation.

Eisai has announced that eribulin should be available in the United States within 10 business days after approval. In addition, the company said it has applied for approvals in the treatment of metastatic breast cancer in Japan, the European Union, Switzerland, and Singapore.

Oncologists have a new Food and Drug Administration–approved option, eribulin mesylate, for patients with metastatic breast cancer that has stopped responding to at least two chemotherapy regimens for early- or late-stage disease.

An injectable microtubule inhibitor, eribulin is a synthetic version of a compound derived from the sea sponge Halichondria okadai. It will be marketed as Halaven by Eisai Inc., a Japanese-owned company based in Woodcliff Lake, N.J.

Before eribulin is introduced, patients should have been treated with taxane- and anthracycline-based regimens, according to the FDA announcement. The agency skipped review by its Oncologic Drugs Advisory Committee, after the new drug proved superior to other single-drug regimens in a company-sponsored phase III clinical trial presented at the American Society of Clinical Oncology’s annual meeting earlier this year.

"There are limited treatment options for women with aggressive forms of late-stage breast cancer who have already received other therapies," said Dr. Richard Pazdur, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research, in the FDA statement. "Halaven shows a clear survival benefit and is an important new option for women."

In the EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician’s Choice Versus Eribulin) trial, eribulin therapy extended overall survival from 10.65 months in a control arm to 13.12 months (P = .041). Eribulin 1.4 mg/m2 was administered on days 1 and 8 every 21 days.

Women in the control group received single-agent treatments chosen by their physicians. Vinorelbine was the most frequent choice, followed by gemcitabine, capecitabine, taxanes, and anthracyclines, Dr. Christopher Twelves, a professor at the University of Leeds in the United Kingdom, reported at the ASCO meeting. The overall response rate was 12.2% for eribulin vs. 4.7% for physician’s choice, he said.

Dr. Twelves described eribulin’s safety profile as consistent with phase II trial data, showing an increase in grade 3 or 4 neutropenia (21% grade 3, 24% grade 4), febrile neutropenia (3%, 1%), fatigue (8%, 0.6%), and neuropathy (7.8%, 0.4%).

According to the FDA announcement, the most common side effects reported by women treated with eribulin include neutropenia, anemia, leukopenia, alopecia, fatigue, nausea, asthenia, peripheral neuropathy, and constipation.

Eisai has announced that eribulin should be available in the United States within 10 business days after approval. In addition, the company said it has applied for approvals in the treatment of metastatic breast cancer in Japan, the European Union, Switzerland, and Singapore.

Oncologists have a new Food and Drug Administration–approved option, eribulin mesylate, for patients with metastatic breast cancer that has stopped responding to at least two chemotherapy regimens for early- or late-stage disease.

An injectable microtubule inhibitor, eribulin is a synthetic version of a compound derived from the sea sponge Halichondria okadai. It will be marketed as Halaven by Eisai Inc., a Japanese-owned company based in Woodcliff Lake, N.J.

Before eribulin is introduced, patients should have been treated with taxane- and anthracycline-based regimens, according to the FDA announcement. The agency skipped review by its Oncologic Drugs Advisory Committee, after the new drug proved superior to other single-drug regimens in a company-sponsored phase III clinical trial presented at the American Society of Clinical Oncology’s annual meeting earlier this year.

"There are limited treatment options for women with aggressive forms of late-stage breast cancer who have already received other therapies," said Dr. Richard Pazdur, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research, in the FDA statement. "Halaven shows a clear survival benefit and is an important new option for women."

In the EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician’s Choice Versus Eribulin) trial, eribulin therapy extended overall survival from 10.65 months in a control arm to 13.12 months (P = .041). Eribulin 1.4 mg/m2 was administered on days 1 and 8 every 21 days.

Women in the control group received single-agent treatments chosen by their physicians. Vinorelbine was the most frequent choice, followed by gemcitabine, capecitabine, taxanes, and anthracyclines, Dr. Christopher Twelves, a professor at the University of Leeds in the United Kingdom, reported at the ASCO meeting. The overall response rate was 12.2% for eribulin vs. 4.7% for physician’s choice, he said.

Dr. Twelves described eribulin’s safety profile as consistent with phase II trial data, showing an increase in grade 3 or 4 neutropenia (21% grade 3, 24% grade 4), febrile neutropenia (3%, 1%), fatigue (8%, 0.6%), and neuropathy (7.8%, 0.4%).

According to the FDA announcement, the most common side effects reported by women treated with eribulin include neutropenia, anemia, leukopenia, alopecia, fatigue, nausea, asthenia, peripheral neuropathy, and constipation.

Eisai has announced that eribulin should be available in the United States within 10 business days after approval. In addition, the company said it has applied for approvals in the treatment of metastatic breast cancer in Japan, the European Union, Switzerland, and Singapore.