FDA approves expansion of Avastin in ovarian cancer
FDA approved bevacizumab (Avastin, Genentech) for patients with platinum-sensitive recurrent epithelial ovarian (psOC), fallopian tube or primary peritoneal cancer.
While Avastin was approved in 2014, this is the first new treatment option for women with psOC in the US in more than a decade. FDA approved Avastin either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine chemotherapy, followed by Avastin alone.
Patients are said to have a ‘platinum-sensitive’ form of the disease if a relapse occurs 6 months or longer following the last treatment with a platinum-based chemotherapy.
“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 Sandra Horning, MD, chief medical officer and head of global product development at Genentech.
Ovarian cancer causes more deaths annually in the United States than any other gynecologic cancer, said David Barley, CEO of the National Ovarian Cancer Coalition (NOCC).
FDA’s approval was based on results from 2 randomized, controlled phase 3 studies, GOG-0213 and OCEANS. The GOG-0213 study demonstrated that adding Avastin to chemotherapy showed an overall survival difference of 5 months compared to chemotherapy alone.
Both the GOG-0213 and OCEANS studies demonstrated a significant improvement in the time women lived without their disease getting worse (progression-free survival, PFS). The GOG-0213 study showed that women lived a median of 3.4 months longer without disease progression with the addition of Avastin to chemotherapy compared to chemotherapy alone. And the OCEANS study showed that Avastin in combination with chemotherapy significantly improved PFS compared to placebo plus chemotherapy (median PFS: 12.4 months vs. 8.4 months).
Overall survival, one of the secondary end points in the OCEANS study, was not significantly improved with the addition of Avastin to chemotherapy.
Adverse events in both studies were consistent with those seen in previous trials of Avastin across tumor types for approved indications, but also included 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.
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