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Roche (RHHBY)'s Avastin Approved in Japan for Treatment of Aggressive Brain Cancer


6/18/2013 7:26:31 AM

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Roche's Avastin approved in Japan for treatment of the most aggressive form of brain cancer

Jun 17, 2013 (Menafn - M2 PRESSWIRE via COMTEX) --Roche (six:RO)(six:ROG)(otcqx:RHHBY) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Avastin (bevacizumab) for the treatment of malignant glioma, including newly diagnosed glioblastoma (GBM) in combination with radiotherapy and temozolomide chemotherapy, and as monotherapy for 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 MD, Roche's Chief Medical Officer and Head of Global Product Development. "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:

* The phase II BRAIN study

* A Japanese phase II study (JO22506)

* The 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 49th annual meeting of the American Society of Clinical Oncology in Chicago.

Applications for first-line treatment have been filed with the health authorities in the EU and Switzerland. Avastin is marketed in Japan by Chugai Pharmaceutical, a member of the Roche Group. Avastin for malignant glioma was designated as an orphan drug in Japan in May 2013, as the estimated number of newly diagnosed malignant glioma and GBM patients per year is about 1,700.

AVAglio is a phase III, randomised, double-blind, placebo controlled trial that assessed the efficacy and safety profile of Avastin in combination with radiotherapy and temozolomide chemotherapy following surgery or biopsy in patients with newly diagnosed glioblastoma. Patients were randomised to one of two arms:

* Avastin plus radiotherapy and temozolomide chemotherapy for six weeks followed by a four-week break. Patients then received Avastin and temozolomide chemotherapy for up to six cycles, followed by Avastin alone until disease progression.

* Radiotherapy, temozolomide chemotherapy and placebo for six weeks followed by a four-week break. Patients then received temozolomide chemotherapy and placebo for up to six cycles, followed by placebo until disease progression.

* Avastin plus radiotherapy and temozolomide chemotherapy significantly reduced the risk of the glioblastoma worsening or death by 36 percent compared to radiotherapy and temozolomide chemotherapy plus placebo (PFS as assessed by trial investigators, a co-primary endpoint: HR=0.64; p

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