Breakthrough cancer treatment Avastin receives first approval in the US

02/27/04

First anti-angiogenesis treatment approved for cancer

Roche today announced that Genentech has received approval from the US Food and Drug Administration (FDA) for Avastin (bevacizumab, rhuMAb-VEGF), an innovative new cancer drug, to be used with intravenous 5-Fluorouracil-based chemotherapy as treatment for patients with previously untreated metastatic cancer of the colon or rectum (first-line treatment). Genentech will market Avastin in the US and expects it to be shipped within three days.

The US approval is based on data from a pivotal Phase III study in over 900 metastatic colorectal cancer patients which demonstrated that patients treated with Avastin plus IFL chemotherapy had a median survival advantage close to five months, compared to patients on chemotherapy alone (20.3 months versus 15.6 months). This represents the largest improvement in survival time reported in a Phase III clinical study attributable to the addition of a single targeted therapy to conventional chemotherapy.

"The remarkable speed with which the FDA has reviewed and approved Avastin is testimony to the groundbreaking scientific and medical importance this treatment brings to cancer patients," said William M. Burns, Head of Roche Pharmaceuticals Division. "This follows a decision by the FDA in 2003 to designate fast track review status to Avastin. In Switzerland and Canada priority review has already been granted and decisions are pending on requests for priority review in the European Union and Australia. We are dedicated to working closely with regulatory authorities to bring Avastin to patients as quickly as possible, particularly as this is the first treatment of its kind."

Avastin is the first anti-angiogenic therapy a totally novel approach to the treatment of metastatic colorectal cancer. The drug targets VEGF (Vascular Endothelial Growth Factor), the central mediator of angiogenesis, thus interfering with the blood supply that is critical to the growth of the tumour, its spread throughout the body (metastasis) and the effective delivery of chemotherapy within the tumour. As this mechanism may be relevant in a number of malignant tumours, Roche and Genentech are presently investigating the potential clinical benefit of the use of Avastin in a number of other forms of cancer, including non-small cell lung cancer, pancreatic, breast and renal cell carcinoma. Large clinical trials are also underway in patients with colorectal cancer that has not spread (adjuvant therapy).

In 2000, colorectal cancer was the third most commonly reported cancer with 945,000 new cases worldwide. It is estimated that over 50% of people diagnosed with colorectal cancer will die of the disease, and it is the most common cancer in developed countries1.

Roche in Oncology
Within the last five years Roche has become the world's leading provider of anti-cancer treatments, supportive care products and diagnostics. Its oncology business includes an unprecedented three marketed products with survival benefit; Herceptin, MabThera and Xeloda, treating a range of malignancies - breast cancer, non-Hodgkin's lymphoma and colorectal cancer. Other key products include NeoRecormon (anaemia in various cancer settings), Bondronat (prevention of skeletal events in breast cancer and bone metastases patients, hypercalcemia of malignancy), Kytril (chemotherapy and radiotherapy-induced nausea and vomiting) and Roferon-A (leukaemia, Kaposi's sarcoma, malignant melanoma, renal cell carcinoma). Roche's cancer medicines generated sales of more than 6 billion Swiss francs in 2003.

Roche is developing new tests which will have a significant impact on disease management for cancer patients in the future. With a broad portfolio of tumour markers for prostate, colorectal, liver, ovarian, breast, stomach, pancreas and lung cancer, as well as a range of molecular oncology tests, we will continue to be the leaders in providing cancer focused treatments and diagnostics.

Roche Oncology has four research sites (two in the US, Germany and Japan) and four Headquarter Development sites (two in the US, UK and Switzerland).

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