Roche Likely to Pursue Avastin Approval in Cervical Cancer Despite

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Published 2013­02­28
Proprietary Intelligence
Roche likely to pursue Avastin approval in
cervical cancer despite niche market ­
experts
Roche (VTX:ROG) is likely to seek approval for Avastin (bevacizumab) in cervical cancer
patients on the back of positive data from a Government­sponsored trial, ovarian cancer
experts said. Despite the small new market opportunity, they explained that adding another
indication that was approved based on overall survival data (OS) is likely to bring more
prescriber confidence in other more lucrative off­label indications. Avastin is an anti­angiogenic monoclonal antibody, approved already in metastatic
colorectal cancer, non­squamous non­small cell lung cancer, glioblastoma, and metastatic
renal cell carcinoma. This news service recently reported that it is seeing extensive off­label
use in the US in ovarian cancer. The cervical cancer study (GOG240) is a National Cancer Institute (NCI) sponsored study. A
Roche spokesperson said: "We look forward to sharing next steps once we have
conducted a full review of the data available." Avastin is not approved for use in cervical
cancer and in general, Roche does not speculate on sales, the spokesperson added. Patients with advanced, recurrent, or persistent cervical cancer that was not curable with
standard treatment who received Avastin lived 3.7 months longer than patients who did
not receive the drug, according to an interim analysis of a large, randomized clinical trial,
according to a 7 February NCI press release. Patients treated with chemotherapy alone had
a median survival of 13.3 months while those who received chemotherapy and
bevacizumab had a median survival of 17 months. The data safety monitoring committee
on the trial recommended publishing the results of the interim analysis because the study
met its primary endpoint of demonstrating improved OS in patients who received Avastin,
which also means that it delayed the chance of dying from the disease, it notes. Full data is
expected at the American Society of Clinical Oncology meeting in Chicago in March. Cervical cancer incidence and prevalence is small but in the US, if approved Avastin, will be
paid for by insurers in this setting, said Andrew Miniuks, senior director, Oncology Market
Access, Kantar Health, UK. It is Roche's decision whether the market value is enough to
warrant seeking market approval, he said. Dr Bradley Monk, professor, division of gynaecologic oncology, Creighton University School
of Medicine, St. Joseph's Hospital and Medical Center, Phoenix, Arizona said the survival
advantage of Avastin in cervical cancer is impressive but it is not clear to anyone what
Roche will do in term of registration. Monk said he totally expected the result and explained
when there is an active drug in a cancer type that has a short average OS time such as
cervical cancer, a good progression free survival signal will translate to OS, but in a slow
growing tumour where the average OS is already long and there are lots of active
treatments, this signal can get lost. We will need to see what Roche's financial analysis shows, because although it is good to
see a new drug for recurrent cervical cancer, cost effectiveness will be even more of an
issue in this population, said Dr Ronald Alvarez, a gynaecological oncologist at the University
of Alabama at Birmingham. Many patients in this population may not be covered by
insurance and therefore rely on Medicaid to pay for it, he noted, which also means if it's not
approved by regulators, these patients will not be able to access it off­label. This is in
contrast to the ovarian cancer population who mostly have insurance and therefore have
the drug reimbursed though private insurers off­label, he said. On the basis of the NCI data, the actual number of patients Avastin use is going to apply to
is going to be very small as it is only for those with current disease, said investigator and
professor Gordon Rustin, Mount Vernon Cancer Centre, Middlesex, UK. Fortunately there
are not that many patients who have this type of disease, he noted. There are no good
treatments at the moment, he added, but said these patients are also likely to have lots of
co­morbidities which could limit treatment with Avastin. The cervical cancer interim analysis is interesting because of the indication and these
patients have a very poor prognosis and there is not much out there to offer them, so
there is a significant unmet need, said Dr Robert Burger, professor of surgical oncology at
the section of gynaecologic oncology, Fox Chase Cancer Center Philadelphia, Pennsylvania.
This tends to be a population with significant health disparities and Burger said he would be
surprised if there was not a lot of political push to get it approved. It is not a large market in the US and there are other countries where cervical cancer is
more endemic, Burger said. But any agent that demonstrates an estimated 30%
improvement in OS advantage without any new safety signals needs to be submitted for
approval, Burger added. However, he did note that due to the fact these results are from
an interim analysis it may be necessary to assess the second analysis. The problem will be
accessibility if not approved, because of the economic status of the average patient in this
group, he agreed. "I think the data is real," Dr Wendel Naumann, associate director, Blumenthal Cancer Center
at Carolinas Healthcare System, Charlotte, North Carolina said, adding that it is a pretty
significant OS advantage. He said he believed the company will use the trial to apply for
marketing authorisation in recurrent cervical cancer as it is a Gynecologic Oncology Group­
lead NCI trial and of a good standard. It is almost certain Roche will apply for approval in the indication, said Dr Maurie Markman,
medical oncologist, MD Anderson Cancer Center, Texas. Roche has a market cap of USD 196bn. by Abigail Moss in London Email the journalist team at [email protected]
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