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~ Health Canada approves Zelboraf, a targeted medicine designed to inhibit cancer growth in patients known to have a common type of metastatic melanoma ~

MISSISSAUGA, ON, Feb. 16, 2012 /CNW/ - Roche announced today that Zelboraf (vemurafenib) was approved in Canada as monotherapy for the treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma. A validated test is required to identify BRAF V600 mutation status.1

Melanoma is the deadliest and most aggressive form of skin cancer, killing 80 to 85 per cent of stage IV patients within five years.2 Approximately half of all patients with melanoma carry a genetic mutation in the BRAF gene.3 Zelboraf is the first and only medicine shown to improve survival in people with BRAF V600 mutation-positive metastatic melanoma. It works by targeting and inhibiting the mutated BRAF protein found in about half of all cases of melanoma.3

"The medical community has been waiting for a treatment that will extend patients' lives while vastly improving quality of life," says Dr. Joel Claveau , Dermatologist, Dermatologist and Pigmented Lesions Clinic, Hospital Hotel-Dieu de Quebec . "Zelboraf is part of an innovative concept called personalized medicine. With a quick genetic test, I can now have the confidence that I'm prescribing the right treatment to patients who will benefit from it."

In the pivotal BRIM3 study in treatment-naïve patients, Zelboraf was shown to reduce the risk of death by 56 per cent for people who received Zelboraf compared to those who received dacarbazine.3  The study also found that participants on Zelboraf had a 74 per cent reduced risk of dying or having their disease progress compared to those who received dacarbazine.3 In another study in patients who failed at least one prior systemic therapy (BRIM2), Zelboraf shrank tumours in 52 per cent of trial participants.3

Mark Wallis , a 49-year-old father of three, is one of the 50 per cent of melanoma patients who has the BRAF mutation. Wallis received Zelboraf as part of the BRIM3 trial.

"The cancer had spread to my liver, my bones, both lungs and numerous lymph nodes so I was in an incredible amount of pain. "I was increasingly worried about my life and how it was going to affect my family," says Wallis, a commercial airline pilot from Milton, Ontario. "Within days of taking Zelboraf, the extreme pain I experienced literally vanished. Within weeks, my tumours had shrunk in size. I felt like I had been given my life back."

Annette Cyr , chair of the Melanoma Network of Canada , lives with melanoma and is all too familiar with the unique challenges patients have faced until now.

"For Canadians living with metastatic melanoma, the approval of Zelboraf brings new hope," says Cyr. "Zelboraf offers BRAF-positive patients a chance to live; to raise their children, to spend time with loved ones and to continue to contribute to society."

Health Canada also recently approved the cobas® 4800 BRAF V600 Mutation Test,4 a diagnostic test developed by Roche to identify patients eligible for treatment with Zelboraf, enabling oncologists to prospectively identify patients who may benefit from the treatment.

"As someone who has been tested positive for the BRAF mutation, I understand the valuable role that Zelboraf can play in the treatment of metastatic melanoma," says Kathy Barnard , Founder, Save Your Skin Foundation. "Patients with melanoma simply don't have the luxury of time and there is tremendous value in knowing right away whether or not a treatment will be effective. Personalized medicines like Zelboraf ensure that patients can receive the best possible care for their type of melanoma."

Personalized medicine is an innovative approach to healthcare that identifies the specific characteristics of a patient's illness, enabling physicians to implement the most effective and efficient treatment plan for each individual patient.5

"We believe that investment in personalized medicines is critical for driving optimal patient care while maximizing the use of limited health care resources," says Ronnie Miller , President and CEO, Roche Canada . "Zelboraf is an innovative, targeted therapy that will deliver effective care and improve outcomes for patients who have been without adequate treatment options for many years."

About BRIM3 and BRIM2

BRIM3 is a global, randomized, open-label, controlled, multicentre, Phase III study that compared Zelboraf to dacarbazine chemotherapy, a standard of care, in 675 patients with previously untreated BRAF V600E mutation-positive, unresectable (inoperable) or metastatic melanoma. The endpoints of BRIM3 were overall survival (OS) and investigator-assessed progression-free survival (PFS). Other endpoints included confirmed investigator-assessed best overall response rate. BRIM2 is a global, single-arm, multicentre, open-label Phase II study that enrolled 132 patients with previously treated BRAF V600E mutation-positive, unresectable or metastatic melanoma. The primary endpoint of BRIM2 was confirmed best overall response rate as assessed by independent review. In BRIM3, a higher percentage of patients treated with Zelboraf (42%) than dacarbazine (18%) experienced serious adverse events (SAEs) and the most common treatment-related SAEs in the patients treated with Zelboraf were cutaneous squamous cell carcinoma (cuSCC).

About BRAF V600 Mutation Testing

The cobas® 4800 BRAF V600 Mutation Test is a real-time polymerase chain reaction assay diagnostic test developed by Roche enabling physicians to identify whether a person with metastatic melanoma is eligible for treatment with Zelboraf. This Health Canada-approved test was clinically validated in the BRIM2 and BRIM3 studies to identify tumors that carry the BRAF V600E mutation. The test is robust, rapid and accurate providing a higher sensitivity in detecting the V600E mutation than Sanger sequencing.9

About Zelboraf

Zelboraf is an oral, small molecule, kinase inhibitor indicated as a monotherapy for the treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma. Zelboraf should not be used in patients with wild-type BRAF melanoma or in patients where the BRAF mutational status is not known.

Zelboraf is being co-developed under a 2006 license and collaboration agreement between Roche and Plexxikon, a member of the Daiichi Sankyo Group.