EU nod for Roche cancer drug and chemotherapy
pharmafile | April 8, 2015 | News story | Sales and Marketing | Cancer, Roche, avastin, bevacizumab, cervical, chemotherapy, wet AMD
The European Commission has approved Roche’s Avastin in combination with standard chemotherapy for women with advanced cervical cancer.
Avastin (bevacizumab) combined with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy – can now be used to treat adult patients with persistent, recurrent or metastatic carcinoma of the cervix.
“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,” says Sandra Horning, chief medical officer and head of global product development at Roche.
The EU approval was based on survival benefit shown in its GOG-0240 study, which demonstrated that women who received Avastin plus chemotherapy had a statistically significant reduction in the risk of death, representing a median improvement in survival of nearly four months, compared to women who received chemotherapy alone.
Also based on the data, Avastin in combination with paclitaxel and cisplatin or paclitaxel and topotecan chemotherapy was approved worldwide last year for the treatment of women with persistent, recurrent or metastatic carcinoma of the cervix.
With the initial green light in the US for advanced colorectal cancer in 2004, Avastin became the first anti-angiogenic therapy made widely available for the treatment of patients with an advanced cancer.
The drug has been in the spotlight just recently following NHS Clinical Commissioners calling for the removal of barriers preventing CCGs from prescribing Roche’s Avastin to treat wet age-related macular degeneration.
This was followed by accusations that Novartis which has the marketing rights to Lucentis (ranibizumab) in Europe, blocked researchers’ efforts to conduct publically-funded trials of Avastin and lobbied the GMC against allowing the off-licence use of Roche’s drug according to the BMJ.
But this latest news in the cervical setting will be welcomed at Roche and indeed worldwide, as it is estimated there are more than half a million cases of cervical cancer every year and over 260,000 deaths from the disease, making it the fourth leading cause of cancer death in women globally.
“Currently, fewer than one in six women with this disease are alive five years after diagnosis. Avastin’s approval is a welcome advance for women with persistent, recurrent or metastatic carcinoma of the cervix,” notes Horning.
Brett Wells
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