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Priority review for Roche’s Avastin in cervical cancer

Will speed up FDA assessment of oncology drug

Roche Avastin bevacizumab cancerRoche's Avastin is to undergo an expedited review process in the US for its use in advanced cervical cancer.

The FDA granted priority review status to the oncology drug for use in combination with chemotherapy for the treatment of women with persistent, recurrent or metastatic cervical cancer.

Priority review is reserved for medicines that offer significant improvements in the safety or effectiveness over current treatments or diagnostic devices. Avastin (bevacizumab) qualifies because it is the only current FDA-approved treatment in this specific cervical cancer indication is chemotherapy.

“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,” said Sandra Horning, chief medical officer and head of global product development at Genentech, Roche's biotech arm responsible for Avastin.

The drug's potential in persistent, recurrent or metastatic cervical cancer has been demonstrated in the GOG-0240 study involving 452 women with the disease.

In this trial there was a 29 per cent reduction in the risk of death for women who received Avastin plus chemotherapy compared to those who received chemotherapy alone. Women in the Avastin plus chemotherapy arm also lived more than two months longer without the disease worsening.

Avastin – a VEGF inhibitor – works by blocking blood supply to tumours and has already proven itself as an effective treatment in several other cancers. Its existing FDA approvals include first-line treatment in non-small lung cancer and in metastatic renal cell carcinoma.

These uses have helped the drug become one of the top 10 biggest-selling pharma products in the world according to PMLiVE's Top Pharma List. In turn, Avastin is one of the main reasons why Roche is the number one company in oncology.

Article by
Thomas Meek

16th July 2014

From: Sales



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