Roche, a global pioneer in pharmaceuticals and diagnostics announced that the European Union’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the use of Avastin (bevacizumab) in combination with Tarceva (erlotinib) for the first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) activating mutations.

NSCLC is the most common type of lung cancer, the leading cause of cancer-related death in Europe and across the world. Approximately 10-15 per cent of Europeans with NSCLC will have tumours with EGFR-activating mutations, representing an estimated 33,000 cases in Europe per year or 90 every day.

“Patients with EGFR mutated lung cancer who were treated with the combination of Avastin plus Tarceva lived significantly longer without their disease progressing compared to patients treated with Tarceva alone,” said Sandra Horning, M.D., chief medical officer and global head of product development. “We are delighted that this strategy of combining targeted medicines has improved patient outcomes. Today’s CHMP opinion brings us one step closer to providing this combination therapy option to patients.”

The EU filing was based primarily on data from the pivotal phase II JO25567 study. In the study, patients who received Avastin plus Tarceva lived a median of 6.3 months longer without their disease progressing (progression-free survival, PFS) compared to those who received Tarceva alone. This represents a statistically significant 46 percent relative reduction in the risk of disease progression or death (median PFS: 16.0 months versus 9.7 months; [HR]=0.54, p=0.0015), meaning the study met its primary endpoint. Avastin and Tarceva each target pathways which are known to be key drivers in the growth and development of tumours, and the beneficial effect of Avastin plus Tarceva is supported by results of other clinical studies which showed the combination was effective and tolerable.

JO25567 is a randomised phase II study conducted by Chugai that assessed the safety and efficacy of first-line Avastin in combination with Tarceva compared to Tarceva alone in Japanese patients with non-squamous NSCLC with EGFR-activating mutations. Study data from 154 patients showed:

Patients who received Avastin plus Tarceva lived a median of 6.3 months longer without their disease progressing (progression-free survival, PFS) (primary endpoint) compared to those who received Tarceva alone, representing a statistically significant 46 percent reduction in the relative risk of disease progression or death (median PFS: 16.0 months versus 9.7 months; [HR]=0.54, p=0.0015).

No new and clinically significant adverse events were observed and the toxicity profile was shown to be managable.

With the initial approval in the United States for advanced colorectal cancer in 2004, Avastin became the first anti-angiogenic therapy made widely available for the treatment of patients with an advanced cancer.

Today, Avastin is continuing to transform cancer care through its proven survival benefit (overall survival and/or progression free survival) across several types of cancer. Avastin is approved in Europe for the treatment of advanced stages of breast cancer, colorectal cancer, non-small cell lung cancer, kidney cancer, ovarian cancer and cervical cancer, and is available in the United States for the treatment of colorectal cancer, non-small cell lung cancer, kidney cancer, cervical cancer and platinum-resistant, recurrent ovarian cancer. In addition, Avastin is approved in over 70 other countries worldwide for the treatment of patients with progressive glioblastoma following prior therapy. Avastin is approved in Japan for the treatment of the advanced stages of colorectal, non-small cell lung cancer, breast cancer, ovarian cancer and malignant glioma, including newly diagnosed glioblastoma.

Avastin has made anti-angiogenic therapy a fundamental pillar of cancer treatment today. Over two million patients have been treated with Avastin so far. A comprehensive clinical programme with more than 300 ongoing clinical trials is investigating the use of Avastin in over 50 tumour types.

Tarceva is a once-daily, oral non-chemotherapy medicine for the treatment of advanced or metastatic NSCLC. It has been shown to inhibit EGFR, a protein involved in the growth and development of cancers. Tarceva is developed and commercialised by Astellas Pharma US in partnership with Genentech in the United States, Chugai in Japan and Roche in the rest of the world.