Lani
09-12-2006, 10:40 AM
FDA Seeks More Data on Avastin
In Breast Cancer
By PETER LOFTUS
September 12, 2006; Page D4
The Food and Drug Administration wants more information before it decides whether to approve Genentech Inc.'s blockbuster drug Avastin as a treatment for advanced breast cancer, the biotechnology company said. The request will probably delay final FDA action until late 2007.
Genentech originally hoped to begin marketing the drug as a treatment for advanced breast cancer by early 2007, assuming the use was approved. Avastin currently is approved for colorectal-cancer treatment. Now, following an FDA request for additional safety and efficacy data, Genentech said it expects to resubmit its application by mid-2007, and an FDA review would likely take an additional six months.
Genentech, of South San Francisco, Calif., has indicated FDA approval for new uses of Avastin such as breast-cancer treatment could help boost the drug's price by about two-thirds -- to nearly $90,000 per patient annually -- because some uses require twice as much of the drug as in colorectal cancer.
"We are disappointed that this will cause a delay in the review of our application, as there is a great unmet medical need for women with metastatic breast cancer," Hal Barron, senior vice president of development and chief medical officer, said in a Genentech press release.
Avastin was approved by the FDA in February 2004 as a treatment for colorectal cancer in combination with chemotherapy and has quickly become a big seller. Last year, Avastin generated U.S. sales of $1.13 billion, more than double the year before. Swiss drug company Roche Holding AG, which owns a majority of Genentech, markets Avastin outside the U.S.
Some of Avastin's sales growth has come from unapproved uses such as treating breast cancer and an eye disease. Genentech is studying Avastin in several additional tumor types, including lung, prostate and kidney cancers. Avastin is designed to work by starving tumors of nutrients.
In May, Genentech applied for FDA approval of Avastin in combination with chemotherapy to treat metastatic breast cancer, or cancer that has spread to other parts of the body. The FDA granted the application priority-review status, which shortened the expected review period to six months from 10 months.
The application in May was based on interim data from a trial that showed women with advanced breast cancer who took Avastin plus chemotherapy had progression-free survival of more than a year, compared with six months for women on chemotherapy alone. Progression-free survival is the time from the start of treatment until tumor growth or death.
The FDA has requested a "substantial safety and efficacy update" from the trial, including an independent review of patient scans for progression-free survival, Genentech said yesterday.
The study was sponsored by the National Cancer Institute, a government research institute, under an agreement between Genentech and the institute. Researchers in the study were led by the Eastern Cooperative Oncology Group, a clinical-research organization.
Genentech said the FDA is requesting the data from the trial be audited and summarized "in a manner typically used for a company-sponsored trial." Genentech said that request was different from its understanding of the FDA's approach when it first submitted the application. Genentech said the request would require re-collection of data from study sites.
A Genentech spokeswoman said cooperative-group studies generally must meet less rigorous standards than company-sponsored trials, citing guidance she said was issued by the FDA in 1998.
"This is certainly a negative surprise and bad for sentiment, especially as this is the second setback for the drug this year, but it's not the end of the world for Avastin," said Tilman Dumrese, analyst in Zurich with private bank Sal. Oppenheim, who covers Roche.
In late June, researchers stopped a trial investigating Avastin's potential in pancreatic cancer after the drug failed to prolong the lives of patients.
---- Anita Greil contributed to this article.
Write to Peter Loftus at peter.loftus@dowjone
In Breast Cancer
By PETER LOFTUS
September 12, 2006; Page D4
The Food and Drug Administration wants more information before it decides whether to approve Genentech Inc.'s blockbuster drug Avastin as a treatment for advanced breast cancer, the biotechnology company said. The request will probably delay final FDA action until late 2007.
Genentech originally hoped to begin marketing the drug as a treatment for advanced breast cancer by early 2007, assuming the use was approved. Avastin currently is approved for colorectal-cancer treatment. Now, following an FDA request for additional safety and efficacy data, Genentech said it expects to resubmit its application by mid-2007, and an FDA review would likely take an additional six months.
Genentech, of South San Francisco, Calif., has indicated FDA approval for new uses of Avastin such as breast-cancer treatment could help boost the drug's price by about two-thirds -- to nearly $90,000 per patient annually -- because some uses require twice as much of the drug as in colorectal cancer.
"We are disappointed that this will cause a delay in the review of our application, as there is a great unmet medical need for women with metastatic breast cancer," Hal Barron, senior vice president of development and chief medical officer, said in a Genentech press release.
Avastin was approved by the FDA in February 2004 as a treatment for colorectal cancer in combination with chemotherapy and has quickly become a big seller. Last year, Avastin generated U.S. sales of $1.13 billion, more than double the year before. Swiss drug company Roche Holding AG, which owns a majority of Genentech, markets Avastin outside the U.S.
Some of Avastin's sales growth has come from unapproved uses such as treating breast cancer and an eye disease. Genentech is studying Avastin in several additional tumor types, including lung, prostate and kidney cancers. Avastin is designed to work by starving tumors of nutrients.
In May, Genentech applied for FDA approval of Avastin in combination with chemotherapy to treat metastatic breast cancer, or cancer that has spread to other parts of the body. The FDA granted the application priority-review status, which shortened the expected review period to six months from 10 months.
The application in May was based on interim data from a trial that showed women with advanced breast cancer who took Avastin plus chemotherapy had progression-free survival of more than a year, compared with six months for women on chemotherapy alone. Progression-free survival is the time from the start of treatment until tumor growth or death.
The FDA has requested a "substantial safety and efficacy update" from the trial, including an independent review of patient scans for progression-free survival, Genentech said yesterday.
The study was sponsored by the National Cancer Institute, a government research institute, under an agreement between Genentech and the institute. Researchers in the study were led by the Eastern Cooperative Oncology Group, a clinical-research organization.
Genentech said the FDA is requesting the data from the trial be audited and summarized "in a manner typically used for a company-sponsored trial." Genentech said that request was different from its understanding of the FDA's approach when it first submitted the application. Genentech said the request would require re-collection of data from study sites.
A Genentech spokeswoman said cooperative-group studies generally must meet less rigorous standards than company-sponsored trials, citing guidance she said was issued by the FDA in 1998.
"This is certainly a negative surprise and bad for sentiment, especially as this is the second setback for the drug this year, but it's not the end of the world for Avastin," said Tilman Dumrese, analyst in Zurich with private bank Sal. Oppenheim, who covers Roche.
In late June, researchers stopped a trial investigating Avastin's potential in pancreatic cancer after the drug failed to prolong the lives of patients.
---- Anita Greil contributed to this article.
Write to Peter Loftus at peter.loftus@dowjone