The Committee for Medicinal Products for Human Use (CHMP), which is responsible for conducting the initial assessment of medicinal products that have been filed for marketing authorisation in Europe, has issued a negative opinion relating to the approval of Avastin (bevacizumab) alone or in combination with irinotecan chemotherapy for the treatment of relapsed or progressive glioblastoma (GBM), the most aggressive type of primary malignant brain cancer.
The filing was based on results from the phase II BRAIN study (AVF3708g).
The major objection from the CHMP was the lack of a comparator arm without Avastin in the BRAIN study, an investigational phase II trial. The CHMP tends to base its approval decisions on Phase III studies only. Roche decided to submit this data set to regulatory authorities globally based on Avastin’s remarkable clinical activity seen in BRAIN.
Roche remains convinced that the results of the BRAIN study, which were published in the Journal of Clinical Oncology in October 20091 are robust and remain valid. Adverse events in the BRAIN study were consistent with those previously seen with Avastin and no new safety signals were reported.
“We are very disappointed with the CHMP opinion which will result in a delay to patients receiving an important new treatment option. We strongly believe that Avastin is a new treatment option for physicians within the EU which would bring hope to GBM patients and their families as it is today in the US and other countries,” said William M Burns, CEO of Roche’s Pharmaceuticals Division.
“Relapsed glioblastoma is a rare condition and represents a very high unmet medical need. These patients deserve effective additional therapies to manage this devastating disease. We remain committed to bringing Avastin to patients with newly diagnosed GBM in Europe.”
In May 2009 Avastin was granted accelerated approval for the treatment of GBM patients with progressive disease following prior therapy from the US Food and Drug Administration (FDA) based on data from the BRAIN study (AVF3708g) and an NCI study (NCI 06-C-0064E). Switzerland and 10 other countries have already recognised the significant clinical benefits Avastin offers to GBM patients by giving approval.
Roche continues to explore further the role of Avastin in GBM through various investigator-led studies. In addition, a large phase III study (AVAGLIO) in more than 900 patients with newly diagnosed GBM is currently underway with the aim of a global filing.
Avastin has proven survival benefits across several types of cancer. It is approved in Europe for the treatment of the advanced stages of four common types of cancer: colorecta cancer, breast cancer, non-small cell lung cancer NSCLC) and kideney cancer.
These types of cancer collectively cause over 2.5 million deaths each year 6,7,8. Over half a million patients have been treated with Avastin so far.