FDA speedy review for new Avastin licence
pharmafile | July 16, 2014 | News story | Research and Development, Sales and Marketing | Cancer, Roche, avastin, cervical cancer
The FDA has granted priority review status for Roche’s Avastin (bevacizumab) plus chemotherapy in women with persistent, recurrent or metastatic cervical cancer.
Another US approval for Genentech, which is wholly owned by Roche, would help considerably in shoring up the drug’s future sales.
“This regulatory application for Avastin is important because chemotherapy is the only approved treatment for women with metastatic, recurrent or persistent cervical cancer,” says Sandra Horning, Roche’s chief medical officer.
“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,” she adds.
Avastin has a number of oncology indications in combination with various treatments in the US, including: metastatic colorectal cancer, non-squamous, non-small cell lung cancer and renal cell carcinoma.
The drug made 1.56 billion Swiss francs ($1.75 billion) in revenue in the first quarter of this year and a new cervical cancer licence could help it reach into the $10 billion a year bracket in the near future.
The FDA has based its decision on cervical cancer on data from the Phase III GOG-0240 trial and is expected to make a decision on it in October.
The trial looked at Avastin plus chemotherapy (paclitaxel and cisplatin or paclitaxel and topotecan) in women in this patient group and met its primary endpoint of improving overall survival (OS).
The treatment reduced the risk of death by 29% in women who received Avastin plus chemotherapy compared to those who received chemotherapy alone (median OS: 17 months versus 13.3 months).
Those in the Avastin arm also experienced better progression-free survival (PFS), living longer without their disease worsening (median PFS: 8.2 months versus 5.9 months).
Hypertension, gastrointestinal or genitourinary fistulas and thromboembolic events were all higher in the Avastin arm although there was no increase in treatment-related deaths.
Estimates suggest that 12,000 new cases of cervical cancer will be diagnosed in the US this year and about 4,000 women will die from the disease.
Adam Hill
Related Content
Central nervous system cancer metastases – the evolution of diagnostics and treatment
The current forms of immunotherapy, how T cell therapy works and what the future holds
Roche receives CE Mark for blood test to help rule out Alzheimer’s
Roche has been granted CE Mark approval for its Elecsys pTau181 test, the first in …
BioMed X and Servier launch Europe’s first XSeed Labs to advance AI-powered antibody design
BioMed X and Servier have announced the launch of Europe’s first XSeed Labs research project, …
