Roche's ($RHHBY) Avastin is now two-for-two on converting recent FDA priority review designations into label expansions. Just three months after the cancer giant nabbed the agency's blessing for use in cervical cancer, regulators have approved the drug in combination with chemotherapy as a treatment for platinum-resistant, recurrent ovarian cancer.
|Sandra Horning, Roche's chief medical officer and head of global product development|
The green light is based on data from the company's AURELIA study, which showed that Avastin cut the risk of the disease worsening by 62% in women who received it with chemotherapy.
"Avastin plus chemotherapy is the first new treatment option for women with this difficult-to-treat type of ovarian cancer in more than 15 years," Sandra Horning, Roche's chief medical officer and head of global product development, said in a statement.
It's the second recent thumbs up for the drug from the FDA, which in August approved it in conjunction with chemo in women with advanced cervical cancer. With that nod, the blockbuster became the first biologic for late-stage cervical cancer ever to win FDA approval, as well as the first new treatment for the disease since 2006.
Both approvals will pad Avastin's top-line haul--not that the med, which came in at No. 7 on the world's list of best-selling drugs last year and rakes in more than any cancer treatment aside from Roche peer Rituxan--needs sales help. Expanded use in colorectal cancer in the U.S. and ovarian cancer approval in Europe helped boost Avastin to $6.75 billion last year, a 13% increase.
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Special Report: Top 10 best-selling cancer drugs of 2013 - Avastin | Top women in biotech 2014 - Sandra Horning, Roche/Genentech