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FDA approves Avastin for ovarian, fallopian tube, peritoneal cancers
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The FDA approved bevacizumab in combination with carboplatin and paclitaxel or carboplatin and gemcitabine chemotherapy for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, according to the drug’s manufacturer.
“With today’s approval of bevacizumab (Avastin, Genentech) plus chemotherapy, women in the United States with recurrent, platinum-sensitive ovarian cancer now have a treatment option that showed a survival difference of more than five months compared to chemotherapy alone in a clinical trial,” Sandra Horning, MD, chief medical officer and head of global product development at Genentech, said 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.”
By the end of 2016, about 22,200 women will be diagnosed with ovarian cancer in the United States, and an estimated 14,200 are expected to die from the disease.
Patients are said to have platinum-sensitive disease if a relapse occurs six months or longer following the last cycle of platinum-based chemotherapy. About half of those who relapse after initial treatment — over 8,000 women — are considered to have platinum-sensitive ovarian cancer.
“This approval demonstrates Genentech’s commitment to women with ovarian cancer, a disease with signs and symptoms that too often go unrecognized,” said David Barley, chief executive officer of the National Ovarian Cancer Coalition.
Bevacizumab was approved in the United States in 2014 for the treatment of women with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan chemotherapy.
Tuesday’s FDA approval of bevacizumab is based on results from two randomized, controlled studies.
The GOG-0213, an independent phase 3 study sponsored by NCI and conducted by the Gynecologic Oncology Group, enrolled 673 women with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer. Assessing whether the addition of bevacizumab to chemotherapy (carboplatin and paclitaxel) followed by continued use of bevacizumab alone increased OS compared to chemotherapy alone served as the primary endpoint. PFS and objective response rate were secondary endpoints.
OCEANS, a company sponsored, placebo-controlled, randomized, multicenter phase 3 study, evaluated the safety and efficacy of bevacizumab, administered in combination with chemotherapy (carboplatin and gemcitabine), in 484 women with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer. PFS, determined using Response Evaluation Criteria for Solid Tumors, served as the primary endpoint. Secondary endpoints included overall response rates, OS and safety.
The GOG-0213 demonstrated that adding bevacizumab to chemotherapy improved patients’ median OS (42.6 months, HR = 0.84; 95% CI, 0.69-1.01) compared with chemotherapy alone (37.3 months, HR = 0.82; 95% CI, 0.68-0.996), depending on stratification factor.
The GOG-0213 study and the OCEANS also showed significant improvement in PFS. In the GOG-0213 study, women reported a favorable median PFS with the addition of bevacizumab to chemotherapy compared to chemotherapy alone (13.8 months vs. 10.4 months, HR = 0.61; 95% CI, 0.51-0.72). The OCEANS study showed that bevacizumab in combination with chemotherapy significantly improved PFS compared to placebo plus chemotherapy (12.4 months vs. 8.4 months; HR = 0.46, 95% CI, 0.37-0.58; P < 0.0001).
OS was not significantly improved with the addition of bevacizumab chemotherapy (HR = 0.95; 95% CI, 0.77-1.17).
Adverse events in both studies were consistent with those seen in previous trials of bevacizumab across tumor types for approved indications, with the addition of fatigue, low white blood cell count with fever, low sodium level in the blood, pain in extremity, low platelet count, too much protein in the urine, high blood pressure and headache.