By: Ron Leuty
From: bizjournals.com
Genentech Inc.’s venerable cancer drug Avastin was approved by federal regulators Friday to treat women with a specific type of ovarian cancer — the first Food and Drug Administration ovarian cancer drug approval in 15 years.
Avastin, which works by cutting off the blood supply to tumors, was approved by the FDA for use in women with platinum-resistant, recurrent ovarian cancer. The drug has already been approved in the United States as a treatment for colon, lung, kidney and cervical cancers as well as the brain cancer glioblastoma.
Cancer is considered “platinum-resistant” if the disease worsens within six months of completing a platinum-based chemotherapy.
Because of Avastin’s other approvals, doctors have been free to use it in ovarian cancer. In fact, South San Francisco’s Oxigene (NASDAQ: OXGN) recently presented data on a 107-patient, mid-stage study of its drug, fostbretabulin, in combination with Avastin versus Avastin alone in women with recurrent ovarian cancer. (Read a good analysis of that study from TheStreet.com.) But FDA approval increases the likelihood that insurers now will pay for it.
Avastin registered 2013 sales of more than 6.2 billion Swiss francs, or about US$6.5 billion, including about $2.7 billion in the United States, according to South San Francisco-based Genentech’s Swiss parent company, Roche. Through the third quarter of this year, it had worldwide sales of 4.7 billion Swiss francs, or about US$5 billion, including U.S. sales of about $2.1 billion.
Ovarian tumors are particularly tough cancers to treat. There are not a lot of easy-to-distinguish symptoms, so women often are diagnosed in the late stages of the disease. Nearly 22,000 U.S. women will be diagnosed with ovarian cancer this year, according to Genentech, while 14,000 will die from the disease.
Specifically, Avastin’s new approval is in combination with the chemotherapies paclitaxel, pegylated liposomal doxorubicin or topotecan in women with platinum-resistant, recurrent, epithelial ovarian, fallopian tube or primary peritoneal cancer who have received no more than two prior chemotherapy regiments.
In the late-phase study used by Genentech to win approval, patients who received a combination of Avastin and one of three types of chemotherapy lived on median 6.8 months without the disease worsening. For patients who received the chemotherapies alone, it was 3.4 months.
Genentech Chief Medical Officer Dr. Sandra Horning said Avastin had “a notable treatment effect” in particular with the chemotherapy drug paclitaxel. According to a Genentech spokeswoman, the study found that women who were given Avastin and paclitaxel lived without the disease worsening for a median of 22.4 months, compared to 13.2 months for those who received paclitaxel alone.
Overall survival — the length of time from the start of a treatment that patients live — was 16.6 months for people given Avastin plus paclitaxel, doxorubicin or topotecan, compared to 13.3 months for those receiving chemo alone. That was not statistically significant, but overall survival was a secondary measure for the study.
Barbara Jacoby is an award winning blogger that has contributed her writings to multiple online publications that have touched readers worldwide.