FDA Approves Avastin Plus Chemotherapy for Advanced Ovarian Cancer

The FDA today expanded the indication of Roche’s bevacizumab (Avastin), allowing the drug to be used to treat several types of platinum-sensitive recurrent ovarian cancer.

Specifically, Avastin can now be used either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine chemotherapy for the treatment of women with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. The disease is considered “platinum-sensitive” if a patient experiences a relapse at least 6 months following her last treatment with a platinum-based chemotherapy.

The agency based its decision on the results of 2 late-stage trials in which the drug’s safety and efficacy were evaluated in a total of 673 women with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

In both studies, researchers found that adding Avastin to chemotherapy led to significant improvements in progression-free survival compared with chemotherapy alone. Additionally, one of the studies indicated that women treated with Avastin and chemotherapy lived an average of 5 months longer than those treated with only chemotherapy; however, the research team of the other study found no significant association between the use of Avastin and overall survival.

“With today’s approval of Avastin plus chemotherapy, women in the US with recurrent, platinum-sensitive ovarian cancer now have a treatment option that showed a survival difference of more than 5 months compared to chemotherapy alone in a clinical trial,” said Roche Chief Medical Officer Sandra Horning, MD, in a press release. “This approval was based in part on a Gynecologic Oncology Group cooperative clinical trial and reinforces the importance of partnerships with study groups to identify new treatment options for people in need.”

The most common adverse events reported by trial participants treated with Avastin and chemotherapy included thrombocytopenia, nausea, dyspnea, epistaxis, hypertension, fatigue, febrile neutropenia, proteinuria, abdominal pain, hyponatraemia, headache, and extremity pain.

Avastin was initially approved in February 2004 for the treatment of metastatic colorectal cancer. The drug’s indication also includes the treatment of several types of lung cancer, brain cancer, kidney cancer, and cervical cancer.