Thursday, Apr 22, 2010

Genentech Submits Supplemental Application to FDA for Herceptin in Advanced HER2-Positive Stomach Cancer

Application Based on Positive Results from International Phase III Study

South San Francisco, Calif. -- April 22, 2010 --

Genentech, Inc., a wholly owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the company submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Herceptin® (trastuzumab) plus chemotherapy in people with advanced, HER2-positive adenocarcinoma of the stomach, including gastroesophageal junction cancer. The application is based on positive results from a Phase III study, known as ToGA, which showed that people who received Herceptin plus chemotherapy lived longer compared to people who received chemotherapy alone.

"This application reflects our commitment to developing more personalized medicines for people with cancer. By using diagnostics to help identify the right patients for our medicines, it is our hope that Herceptin used with chemotherapy will become the first targeted option for advanced HER2-positive stomach cancer," said Hal Barron, M.D., executive vice president, Global Development and chief medical officer. "We look forward to working with the FDA and the diagnostic company on this application."

About the Study (ToGA)
The international Phase III study enrolled 594 people with locally advanced or metastatic HER2-positive stomach cancer who were randomized to receive Herceptin plus chemotherapy (Xeloda® [capecitabine tablets] or intravenous 5-flourouracil and cisplatin) or chemotherapy alone. Overall survival (OS), the primary endpoint, was significantly improved in people who received Herceptin plus chemotherapy compared to those who received chemotherapy alone (HR=0.74, p=0.0046, median OS 13.8 vs. 11.1 months). No new or unexpected adverse events were seen in the Herceptin patient group, and no statistically significant difference in symptomatic congestive heart failure was seen between the two groups (one person in the Herceptin group and two people in the comparison group experienced heart failure). All people in this trial were tested for their HER2 status using diagnostics developed by Dako.

In 2009, the American Society of Clinical Oncology (ASCO) named the results of ToGA as one of the major cancer research advances of the year.

About Stomach Cancer
According to the American Cancer Society (ACS), an estimated 21,130 Americans were diagnosed with stomach cancer and more than 10,600 Americans died from the disease in 2009. More than 64,000 Americans are currently living with the disease. Early diagnosis is challenging because many people do not have symptoms until the disease has advanced into late stages when the tumor cannot be surgically removed or has spread to other parts of the body.

Cancer of the stomach or the area where the stomach and esophagus join (gastroesophageal junction) can be further divided into categories based on the genetics of the tumor, such as human epidermal growth factor receptor 2 (HER2)-positive and HER2-negative (sometimes referred to as "HER2-normal"). In ToGA, about 22 percent of stomach cancers were HER2-positive. There are unique aspects to HER2 testing for stomach cancer that may impact a HER2-positive or HER2-negative diagnosis.

About Herceptin
Herceptin is approved for one year of adjuvant treatment for HER2-overexpressing node-positive or node-negative (ER/PR-negative or with one high-risk feature) breast cancer:

  • As part of a treatment regimen containing doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel
  • With docetaxel and carboplatin
  • As a single agent following multi-modality anthracycline-based therapy

Herceptin is also approved for metastatic breast cancer:

  • In combination with paclitaxel for the first-line treatment of HER2-overexpressing metastatic breast cancer
  • As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease

Important Safety Information
Herceptin treatment can result in heart problems, including those without symptoms (reduced heart function) and those with symptoms (congestive heart failure). Some patients have had serious infusion reactions and lung problems; fatal infusion reactions have been reported.
Worsening of low white blood cell counts associated with chemotherapy has also occurred. Herceptin can cause low amniotic fluid levels and harm to the fetus when taken by a pregnant woman. The most common side effects associated with Herceptin were fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, shortness of breath, rash, low white and red blood cells, and muscle pain. Because everyone is different, it is not possible to predict what side effects any one person will have. Patients with questions or concerns about side effects should talk to their doctor.

For Herceptin full prescribing information, including Boxed WARNINGS and additional important safety information, please visit www.herceptin.com.

About Xeloda
Xeloda is used to treat:

  • Cancer of the colon or rectum (colorectal cancer) that has spread to other parts of the body (metastatic colorectal cancer). Xeloda is used as a single drug to treat metastatic colorectal cancer. You should know that in studies, other medicines showed improved survival when they were taken together with 5-FU and leucovorin. In studies, Xeloda used as a single drug was no worse than 5-FU and leucovorin taken together, but did not improve survival compared to these two medicines.
  • Cancer of the colon after surgery.
  • Breast cancer that has spread to other parts of the body (metastatic breast cancer) together with another medicine called docetaxel.
  • Breast cancer that has spread to other parts of the body and has not improved after treatment with other medicines such as paclitaxel and anthracycline-containing medicine such as doxorubicin.

Xeloda Boxed WARNINGS and Additional Important Safety Information
Xeloda may increase the effect of blood thinning medicines, such as warfarin and other coumarin derivatives, and could lead to serious side effects if taken at the same time as these medicines. It is very important that doctors closely monitor patients who are taking blood thinning medicines and Xeloda, checking more often how quickly their patients' blood clots and, if needed, changing the dose of the blood thinning medicine.

The most common side effects of Xeloda are: diarrhea, nausea, vomiting, sores in the mouth and throat (stomatitis), stomach area (abdominal) pain, upset stomach, constipation, loss of appetite, and too much water loss from the body (dehydration). These side effects are more common in patients age 80 and older. Other common side effects are hand-and-foot syndrome (tingling, numbness, pain, swelling or redness in the palms of the hands or soles of the feet); rash; dry, itchy or discolored skin; nail problems; hair loss; tiredness; weakness; dizziness; headache; fever; pain (including chest, back, joint and muscle pain); trouble sleeping; and taste problems. Patients should tell their doctor if they have heart problems because they could have more side effects related to their heart.

These side effects may differ when taking Xeloda with docetaxel. Patients should consult their doctor for possible side effects that may be caused by taking Xeloda with other therapies.

Women should not become pregnant while taking Xeloda and should not take Xeloda while nursing a baby.

For full Prescribing Information, including Boxed WARNINGS and important safety information on Xeloda please visit www.xeloda.com.

About Genentech
Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines for patients with serious or life-threatening medical conditions. The company, a wholly owned member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit www.gene.com.

###