How is lung cancer treated in Europe?

Roche today announced that the European Committee of Human Drug Products (CHMP) issued a positive recommendation for the first use of Avastin in the treatment of the most common form of lung cancer, along with platinum-based chemotherapy. This CHMP decision is based on data from a major US study (E4599) and another Avastin study in the lungs (Avail) stage III which equally demonstrates that Avastin is potent along with a wide range of chemotherapy.

lung cancer viruses

Lung cancer results in more than 3,000 deaths per day worldwide (1) and non-small cell lung cancer (NSCLC) is the most common form of the disease that accounts for more than 80 percent of all lung cancers. (2) Avastin is the only treatment first in more than a decade that has been proven to prolong the life of people with advanced lung cancer in which patients usually have an average life expectancy of only 8 to 10 months.

"This is an important day for doctors and patients because it facilitates Avastin, with its proven ability to prolong the life of a very difficult disease to treat, one step ahead of reality," says Professor Christian Mane gold, Heidelberg University Medical Sciences Professor Medical University, Mannheim, Germany as well as Head of Researcher Avail study. "I believe that Avastin is an innovative drug that will not only change the current standard of NSCLC treatment, but it will also improve our expectations of cure."

Avastin is the first and only anti-antigenic drug that has been shown to keep improving overall and / or free survival of colorectal, lung, breast, and kidney disease diseases.

"This CHMP opinion is good news for Europeans who have a malignant and crippling disease," said William M. Burns, Chief Executive Officer of the Roche Drug Division. "With the development of our Avastin program - which is the largest trial program in oncology - we will continue to develop the best possible treatment approach to improve survival and improve the quality of life of cancer survivors."

In Europe, Avastin was approved as the first treatment of metastatic colorectal cancer in January 2005 and in the US in February 2004. He obtained approval again in the US in June 2006 as the second treatment of metastatic colorectal cancer patients. In October 2006, following a preliminary review, the world's first angiogenesis inhibitors were approved by the FDA for the treatment of NSCLC. More recently in April 2007, Avastin was approved in Europe for the first treatment of women with metastatic breast cancer and in Japan for use in advanced or recurrent colorectal cancer.

About the Phase III study that forms part of the data packet submitted to CHMP

E4599 Review

Results of a randomized, multicentre controlled E4599 stage III study of 878 patients with locally advanced, metastatic or recurrent latex non-small (NSCLC) lung cancer, with histology other than scaled cells more prominent, suggesting that the average survival of treated patients with Avastin at a dose of 15 mg / kg every three weeks plus chemotherapy duration of 12.3 months, compared with 10.3 months for patients treated with chemotherapy alone. Patients who received Avastin at a dose of 15mg.kg every three weeks plus paclitaxel and carboplatin increased overall survival by 25 percent, compared with patients who received chemotherapy alone. Side effects can usually be controlled. Cases of pulmonary haemoptysis appear in 2.3 percent of patients receiving Avastin plus chemotherapy. The most common adverse side effects of Avastin's single treatment are: hypertension (5.6 percent), proteinuria (4.2 percent), fatigue (5.1 percent) and dyspnoea (5.6 percent). (3)

Avail review

In a randomized, controlled Avail study of results of unknown subjects and objects, patients were given Avastin treatment at 7.5 mg / kg or 15 mg / kg + cisplatin / gemcitabine or placebo + cisplatin / gemcitabine. This study involved more than 1,000 people worldwide who had previously untreated NSCLC, with histology apart from more prominent scaly cells. The results showed that by adding Avastin to cisplatin / gemcitabine administration, progression-free survival was significantly extended by 20 to 30 percent compared with chemotherapy alone. No apparent adverse or novel adverse effects.