Roche nabs EU approval for Avastin for cervical cancer

Roche’s ($RHHBY) Avastin has been on the market for more than a decade and boasts a long list of valuable approvals. But Roche is not sitting back the status quo, and continues to submit the drug for new uses. Now, the company racked up yet another OK for Avastin, scoring European approval for the drug in combination with chemotherapy to treat women with advanced cervical cancer months after the company got a similar decision from stateside regulators.

The EU regulatory green light was based on data from a GOG-0240 study of 452 women, which found that Avastin plus chemotherapy reduced patients’ risk of death by 26% and extended their survival rate by an average of four months, the company said in a statement. Women who received Avastin and chemotherapy also had a higher rate of tumor shrinkage than those who only got chemotherapy.

An estimated 33,000 women will be diagnosed with cervical cancer in the EU this year and 13,000 women will die from the disease, according to a Roche press release. Chances of survival improve if the cancer is caught earlier, but early symptoms can be easily overlooked and many women do not receive a diagnosis until the cancer has progressed.

“We are pleased that women in Europe now have a much needed new treatment option that is proven to help them live longer lives compared to chemotherapy alone,” Sandra Horning, Roche’s Chief Medical Officer, said in a statement. “Currently, fewer than one in 6 women with this disease are alive 5 years after diagnosis. Avastin’s approval is a welcome advance for women with persistent, recurrent or metastatic carcinoma of the cervix.”

In August, Roche got an FDA nod for Avastin in combination with chemotherapy in women with advanced cervical cancer two months before its deadline. The drug is the first biologic for late-stage cervical cancer approved by the agency and the first new treatment for the disease to hit the market since 2006.

Since then, Roche has pushed for more label expansions of the drug. In November the company scored an FDA OK for Avastin for use in ovarian cancer in combination for chemotherapy. Regulators based their decision on data from Roche’s AURELIA study, which showed that Avastin reduced the risk of the disease worsening by 62% in women who received the drug with chemotherapy.

New approvals can only help Avastin’s numbers, as the drug continues to rake in big bucks for Roche’s cancer franchise. In 2013, sales of the med shot up 13% to $6.75 billion. And the Basel-based drugmaker saw a 6% spike in Avastin sales in 2014 after gaining more regulatory blessings for the med.

http://www.fiercepharma.com/story/roche-nabs-eu-approval-avastin-cervical-cancer/2015-04-08

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