Roche’s blockbuster cancer drug Avastin has been approved in Japan for treatment of the most aggressive form of brain cancer.
The Japanese drug regulator has approved Roche’s Avastin (bevacizumab) for malignant glioma and newly diagnosed glioblastoma (GBM), in combination with radiotherapy and temozolomide chemotherapy.
It also approved as a monotherapy for the treatment of recurrent GBM and certain other types of high-grade glioma following prior therapy.
Current treatment options for malignant glioma are limited, and Avastin represents the first new medicine approved worldwide for newly diagnosed glioblastoma, the most common and aggressive form of primary brain cancer, in the last eight years.
“This approval of Avastin is important news for people in Japan who have been diagnosed with glioma and glioblastoma because aggressive brain cancer can significantly reduce a person’s quality of life and the ability to perform everyday activities,” said Hal Barron, Roche’s chief medical officer.
“People with newly diagnosed glioblastoma who received Avastin plus radiotherapy and temozolomide chemotherapy in the pivotal study experienced a significantly longer period of time without their cancer worsening.”
The approval was based on data from three clinical studies in GBM, including two mid-stage studies and a pivotal phase III AVAglio study, which demonstrated that when Avastin was added to standard treatment, patients lived significantly longer without their disease getting worse.
Final results from the AVAglio study in newly diagnosed GBM patients were recently presented at the American Society of Clinical Oncology (ASCO) conference in Chicago earlier this month.
The estimated number of newly diagnosed malignant glioma and GBM patients per year is about 1,700 in Japan.
Avastin regaining revenue
Roche said that applications for first-line treatment have also been filed with the health authorities in the EU and Switzerland.
Avastin currently has a licence for the second-line treatment of glioblastoma from the FDA, but Roche did not say that it was seeking anything further from this licence in the US.
The drug currently has five oncology licences in Europe: colorectal, kidney, ovarian, lung and a restricted breast cancer indication, but the EMA has long refused the drug a licence for brain tumours.
The European regulator has to date remained unconvinced of the drug’s efficacy in glioblastoma, but Roche will hope the new AVAglio study will help convince the EMA, and in turn increase the $6bn plus in revenue the drug has been bringing in for the firm.
The treatment is the biggest selling cancer drug in the world, but took a hit in 2011 when new studies showed that it was not as efficacious as first thought in breast cancer.
After the publication of these studies, the FDA decided to revoke its licence in this area, with the EMA restricting its use in breast cancer, decisions that cut around a $1bn from its revenue figures.
But since then a European approval in ovarian cancer and today’s announcement that Japan – still pharma’s second biggest market – has given the green light for brain cancer should help replace those lost sales for the drug.