The U.S. Food and Drug Administration has granted priority review designation for the use of Avastin (bevacizumab) plus chemotherapy for the treatment of patients with persistent, recurrent, or metastatic cervical cancer. The FDA action date is October 24, 2014. Currently chemotherapy is the only approved treatment for such patients, the manufacturer, Genentech, noted in a news release.
The FDA's priority review designation shortens the time to complete a drug's review and aims to deliver a decision on marketing approval designation for drugs that may offer major advances in treatment or provide a treatment where no adequate therapy exists within six months under the Prescription Drug User Fee Act (PDUFA).
The drug's application is based on data from the Phase III GOG-0240 trial, which evaluated the efficacy and safety profile of Avastin plus chemotherapy (paclitaxel and cisplatin or paclitaxel and topotecan) in 452 women with persistent, recurrent, or metastatic cervical cancer.
The data showed a 29 percent reduction in the risk of death for women who received Avastin plus chemotherapy compared with those who received chemotherapy alone; and women who received Avastin plus chemotherapy also lived longer without disease worsening compared with those who received chemotherapy alone (8.2 vs. 5.9 months).
The most common adverse events reported for the women receiving Avastin were grade 2 or higher hypertension (25% of the patients), gastrointestinal or genitourinary fistulas (6%), and thromboembolic events (8%).
The FDA also granted priority review designation for the use of Avastin (bevacizumab) plus chemotherapy for the treatment of patients with recurrent, platinum-resistant ovarian cancer. The FDA action date for Avastin for this indication is November 19, 2014.
Approximately 25 percent of women with ovarian cancer will have platinum-resistant disease at the time of a first recurrence, a Genentech news release notes.
The drug's application is based on data from the multicenter, randomized Phase III AURELIA trial, which included 361 women with platinum-resistant, recurrent epithelial ovarian, primary peritoneal or fallopian tube cancer who had received no more than two anticancer regimens prior to enrollment in the trial. The women were randomized to receive one of six treatment regimens for the trial (paclitaxel, topotecan, or liposomal doxorubicin-each with or without Avastin). The data showed:
* Avastin plus chemotherapy prolonged progression-free survival (PFS) by 52 percent compared with chemotherapy alone (PFS was 6.7 months for women taking Avastin vs. 3.4 months for those receiving just chemotherapy);
* The women receiving Avastin plus chemotherapy had a significantly higher rate of tumor shrinkage compared with chemotherapy alone when evaluated by the RECIST criteria; and
* Grade 3 to 5 adverse events occurred at a higher incidence in women receiving Avastin plus chemotherapy compared with women receiving chemotherapy alone. Those adverse events were hypertension (seen in 7% of the women receiving Avastin vs. 1% of those receiving just chemotherapy), proteinuria (2% vs. 1%), and gastrointestinal perforations (2% vs. 0%).
Avastin is currently approved for use in combination with fluoropyrimidine-based irinotecan or fluoropyrimidine/oxaliplatin-based chemotherapy to treat patients with metastatic colorectal cancer whose disease has progressed after a first-line bevacizumab-containing regimen (OT 2/25/13 issue); and the drug is also approved for use in combination with intravenous fluorouracil-based chemotherapy to treat patients with first-line or previously untreated metastatic colorectal cancer (OT 3/25/04 issue).