Genentech, a member of the Roche Group, recently announced that its Avastin (bevacizumab) was granted Priority Review for treatment of women with persistent, recurrent or metastaticcervical cancer.
The US Food and Drug Administration (FDA) accepted for review and granted the company’s supplemental Biologics License Application (sBLA) Priority review for Avastin plus chemotherapy in this patient population.
The priority review status means the agency will provide a speedier review of Avastin for this indication. The application is a priority since chemotherapy is currently the only approved treatment for women with metastatic, recurrent or persistent cervical cancer. With priority review, the Prescription Drug User Fee Act (PDUFA) date is October 24.
The sBLA included data from the Phase III GOG-0240 trial, which assessed the efficacy and safety of Avastin plus chemotherapy in 452 women with the disease. In the late-stage trial, Avastin when added to chemotherapy helped prolong the lives of women with metastatic, recurrent or persistent cervical cancer. The study met its primary endpoint of a statistically significant improvement in overall survival (OS), with a 29 percent reduction in the risk of death for women who received Avastin plus chemotherapy versus those who received chemotherapy alone. Additionally, the drug extended the time women experienced without disease worsening, with a median progression-free survival (PFS) of 8.2 months for those receiving Avastin plus chemotherapy compared to a median of 5.9 months for those receiving chemotherapy alone.
“This regulatory application for Avastin is important because chemotherapy is the only approved treatment for women with metastatic, recurrent or persistent cervical cancer,” said Sandra Horning, MD, chief medical officer and head of Global Product Development. “Treatment with Avastin plus chemotherapy may help women with these conditions live longer than chemotherapy alone, and we look forward to working with the FDA on potentially making this medicine available to patients.”
In 2014, it is estimated that more than 12,000 new cases of cervical cancer will be diagnosed in the US and about 4,000 will die from the disease. When diagnosed early, survival rates are significantly higher, with at least nine out of ten women living for five years following diagnosis of early stage disease. However, when diagnosed with advanced cervical cancer, the survival rate drops significantly, with one in six women living for five years following diagnosis of metastatic cervical cancer.
Avastin is already approved in the US for treatment of a variety of cancers including colon, lungs and kidneys. In the first quarter of 2014, the drug brought in $1.75 billion in revenue.
Last updated: 7/16/14; 11:05am EST