Health Canada approves anti-cancer agent TARCEVA® as first-line therapy in genetically distinct type of non-small cell lung cancer

MISSISSAUGA, ON, Aug. 13, 2012 /CNW/ - Roche Canada announced today Health Canada's approval of an additional indication for TARCEVA® (erlotinib), a tyrosine kinase inhibitor (TKI) used in the treatment of metastatic non-small-cell lung cancer (mNSCLC). The new approval for TARCEVA, as a first-line therapy for patients with activating mutations of the epidermal growth factor receptor (EGFR) with mNSCLC, adds to the existing indications for TARCEVA in the first-line maintenance as well as second- and third-line settings of mNSCLC irrespective of mutational status.

"TARCEVA has significantly extended the time people lived without disease progression as compared to chemotherapy for this specific patient population," said Dr. Vera Hirsh, Oncologist, McGill University Health Centre. "This new indication allows physicians to personalize early treatment according to EGFR activating mutation status, while people with NSCLC without EGFR activating mutations will continue to benefit from treatment with TARCEVA in later lines of therapy."

The use of TARCEVA in patients with mNSCLC and activating EGFR mutations is supported by a Phase III European Randomized Trial of TARCEVA vs. Chemotherapy (EURTAC). This trial is the first and only prospective phase III study in Caucasian patients (previous TKI studies involved only Asian populations) with mNSCLC harbouring the EGFR activating mutations. EURTAC demonstrated TARCEVA significantly extended the time people lived without disease progression versus chemotherapy in EGFR activating mutation-positive NSCLC. The trial showed that in Caucasian patients, first-line TARCEVA nearly doubled median progression free survival (9.7 vs. 5.2 months; HR=0.37; p<0.0001) and more than tripled the response rate (58% vs. 15%) compared to chemotherapy.ⁱ Presented at ASCO 2011 by Zhou et al, the OPTIMAL study provides additional evidence that first-line use of TARCEVA extended progression free survival to more than one year (median 13.7 vs. 4.6 months with chemotherapy, HR=0.16, p<0.0001).ⁱⁱ

"TARCEVA was first approved in 2005 for the treatment of patients with locally advanced and metastatic NSCLC after failure with chemotherapy. TARCEVA was the first and only TKI to show an overall survival improvement in this setting," said Brian Jahns, Vice President, Oncology, Roche Canada. "With this latest Health Canada approval, TARCEVA continues to provide physicians with treatment options in additional NSCLC patient populations. Roche is proud to continue to bring treatment options to patients facing this devastating disease."

About Lung Cancer
In 2012, an estimated 25,600 Canadians will be diagnosed with lung cancer and 20,100 will die of it. Lung cancer remains the leading cause of cancer death for both men and womenⁱⁱⁱ - roughly equal to the incidence of breast and prostate cancers. Lung cancer accounts for more than a quarter (27%) of all cancer deaths each year; breast and prostate cancers also account for over a quarter (28% in women and 27% in men respectively) of new cancer cases.^iv Lung cancer can be broadly divided into two major types - NSCLC and small-cell lung cancer. NSCLC is the most prevalent and accounts for approximately 85 percent of all cases. It is estimated that as many as one-in-ten (10%) Caucasians and one-in-three (30%) Asians have EGFR activating mutations in NSCLC.^v

About EGFR in Lung Cancer
EGFR is a protein that extends across the cell membrane. The epidermal growth factor (EGF) binds to the part of the EGFR protein that sits on the outside of the cell.^vi Binding leads to activation of the EGFR protein, which triggers a complex signaling cascade inside the cell that leads to a series of events, including accelerated cell growth and division, and development of metastases (tumour growth and spread to other parts of the body).^vii,viii Some NSCLC tumours have activating mutations in the EGFR gene, changing the structure of the EGFR proteins such that they have increased activity.

About TARCEVA
TARCEVA is a once-daily, oral, non-chemotherapy medicine for the treatment of advanced or metastatic NSCLC. It has been shown to have the potential to inhibit EGFR. TARCEVA was approved as a first-line therapy for patients with activating mutations of the EGFR with mNSCLC in Canada on July 20, 2012. TARCEVA is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen, and whose EGFR expression status is positive or unknown; and as monotherapy for maintenance treatment in patients with locally advanced or metastatic NSCLC with stable disease after four cycles of standard platinum-based first-line chemotherapy.

About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2011, Roche had over 80,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 42.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. Roche Canada was founded in 1931. The company employs approximately 900 people across the country, with its pharmaceuticals head office located in Mississauga, Ontario and diagnostics division based in Laval, Quebec. Roche Canada is actively involved in local communities, investing in charitable organizations and partnering with healthcare institutions across the country. For more information, visit www.rochecanada.com.

All trademarks used or mentioned in this release are protected by law.

References
_________________________________
ⁱ Rafael R. et al. Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial. The Lancet Oncology, Volume 13, Issue 3; 239-246: March 2012.
ⁱⁱ C. Zhou, Y.L. Wu, G. Chen et al. Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study. Lancet Oncol, 12; 735-742: 2011.
ⁱⁱⁱ http://www.cancer.ca/canada-wide/about%20cancer/cancer%20statistics/stats%20at%20a%20glance/lung%20cancer.aspx?sc_lang=en. Accessed July 2012.
^iv http://www.cancer.ca/Canada-wide/About%20cancer/Cancer%20statistics/Stats%20at%20a%20glance/General%20cancer%20stats.aspx?sc_lang=en. Accessed July 2012.
^v Rosell R. et al. NEJM, 361; 1-10-: 2009.
^vi http://www.cancer.gov/aboutnci/ncicancerbulletin/archive/2008/051308/page3. Accessed July 2012.
^vii Prenzel N. et al. Endocrine-Related Cancer 8; 11-31: 2001.
^viii Britten C.D. Mol Cancer Ther, 3; 1335-42: 2004.

SOURCE: Roche Canada

For further information:

Nancy Zorzi
Roche Canada
[email protected]
905-542-5555 ext. 4227