Genentech Breast Cancer and Asthma Drug Updates
Genentech’s breast cancer drug, Perjeta, has extended the lives of people with breast cancer while the label for its asthma drug, Xolair, has been updated to include potential heart risks.
About the Genentech Drug Updates
According to the San Francisco Chronicle, Perjeta is a breast cancer drug that extended the lives of people with an aggressive type of metastatic breast cancer. The median overall survival of about 5 years is the longest survival observed to date. Perjeta was approved in the United States in 2012, and previous analyses had suggested that the drug increased survival by a significant amount. The trial completed currently followed up with patients to show just how long. More details of the drug’s success can be found below.
However, the drug label for Genentech’s asthma drug (jointly developed by Novartis), Xolair, has been changed by the Food and Drug Administration (FDA) to include warnings about potential heart and brain blood vessel risks. Xolair was approved in 2003 to treat patients 12 and older with moderate to severe asthma. The FDA also approved the drug to patients with chronic hives without a known cause (called chronic idiopathic urticarial). More details of the increased risk can be found below.
Genentech and Novartis are working closely with the FDA to increase the understanding of their medicine and update drug label information.
Description of the Perjeta and Xolair Drugs
More information about the Perjeta success:
- The trial involved people who had previously not been treated for a form of breast cancer called HER2-positive metastatic breast cancer.
- They patients were given Perjeta plus Herceptin and chemotherapy and compared to a group who just received Herceptin and chemotherapy.
- The Perjeta group lived almost 16 months longer than the control group.
- The good results mean Perjeta could become even more widely used.
More information on the Xolair risks:
- The FDA reviewed a 5 year safety study of the drug and found a slightly increased risk of problems involving the heart and blood vessels to the brain.
- These medical issues include mini-strokes known as transient ischemic attacks; heart attacks; sudden, unexpected chest pain; high blood pressure in the arteries of lungs called pulmonary hypertension; and blood clots in the lungs and veins.
- Due to weaknesses in how the study was designed, the FDA was unable to determine exactly how big the risks are.