Lani
01-27-2006, 12:59 AM
Each approved targetted therapy that can be used off-label adds one more possible drug for those running out of options...
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FDA Approves Pfizer Drug for Two Cancers
By SCOTT HENSLEY, RON WINSLOW and ANNA WILDE MATHEWS
Staff Reporters of THE WALL STREET JOURNAL
January 27, 2006; Page B1
The U.S. Food and Drug Administration yesterday approved Pfizer Inc.'s drug Sutent to treat two deadly cancers, providing a boost for the beleaguered drug giant and offering more promise for a burgeoning approach in fighting tumors.
Sutent, a once-a-day-pill, was approved to treat advanced kidney cancer, for which there are few remedies, and a rare stomach cancer that fails to respond to Novartis AG's blockbuster cancer drug Gleevec. It marked the first time the FDA has approved a drug for two different cancers on the same day.
Pfizer says it expects the average price per six-week treatment cycle with Sutent to be about $4,000 and the yearly cost to be about $38,000. The drug is expected to be available to patients on Feb. 3.
"Victory is sweet, and it's been a great day for us across the board," says John LaMattina, president of research and development at Pfizer. Sutent is the first cancer drug developed by Pfizer to be approved by the FDA. The experimental medicine was acquired through Pfizer's purchase of Pharmacia Corp. three years ago.
Sutent is one of a new group of targeted therapies that attack tumor cells by disrupting the signals that enable them to multiply. Gleevec was among the first such treatments and helped launch what oncologists hope will be an effective strategy for stanching tumors and prolonging survival of cancer patients with fewer side effects than those that accompany conventional chemotherapy. Sutent goes a step further: It inhibits the growth of blood vessels that feed tumors and allow them to spread to other parts of the body.
"This proves that Gleevec wasn't some lucky one-off," says George Demetri, a researcher at Dana-Farber Cancer Institute who led the study that resulted in the approval of the drug to treat the stomach cancer known as GIST, for gastrointestinal stromal tumor. "Here we have solid evidence that you can take research about the mechanisms underlying the signals that affect tumors, develop drugs to shut down those signals and help patients."
The FDA allowed both uses of Sutent based on results that didn't include extensions of patients' survival. Indeed, the drug doesn't cure either cancer. For GIST, approval was based on evidence that when patients took Sutent, the growth of their tumors was slowed. The time to progression of the tumors was 27 weeks, compared with six weeks for those who didn't take the drug. Approval for use for kidney cancer was based on patients' tumors shrinking by at least 50% -- a result that occurred in 26% of patients in one study and 37% in another, the agency said.
The immediate market appears to be small. About 32,000 new cases of kidney cancer and 5,000 GIST cancers are diagnosed each year, according to the American Cancer Society. But cancer doctors routinely try approved treatments for so-called off-label uses. Sutent is also being tested as a treatment for breast cancer, colon cancer and a form of pancreatic cancer, among others.
"The fact that it got approved for two very different, very difficult-to-treat solid tumors on the same day makes us fairly optimistic about future research," says Dana-Farber's Dr. Demetri.
The agency said the most common side effects were diarrhea, skin discoloration, mouth irritation, weakness and altered sense of taste. The agency said the drug is given orally, 50 milligrams a day for four weeks, followed by a two-week break.
The FDA's approval of the kidney-cancer use was an "accelerated approval," which means that Pfizer will return to the agency with further results demonstrating the drug's effectiveness.
The FDA has come under fire from companies over their perception that the agency is taking a cautious approach on drug approvals in the wake of questions over drug safety. It underlined the news of the approval by holding a press conference and emphasizing its quick action in a press release. Pfizer filed for approval last August. "I really believe this is an advance," says Richard Pazdur, director of the FDA's office of oncology drug products.
For Pfizer, the progress in cancer and diabetes drugs provides support for some of its highest-risk research projects. Exubera was delayed for years in both the U.S. and Europe over worries the drug might damage breathing capacity with long-term use.
Pfizer aims to become a major supplier of cancer treatments, which are highly profitable and require less spending on sales and marketing than drugs prescribed by primary-care doctors. The company already sells some cancer drugs that it acquired through Pharmacia, including Aromasin and Ellence for breast cancer and Camptosar for colorectal cancer.
Write to Scott Hensley at scott.hensley@wsj.com, Ron Winslow at ron.winslow@wsj.com and Anna Wilde Mathews at
.
FDA Approves Pfizer Drug for Two Cancers
By SCOTT HENSLEY, RON WINSLOW and ANNA WILDE MATHEWS
Staff Reporters of THE WALL STREET JOURNAL
January 27, 2006; Page B1
The U.S. Food and Drug Administration yesterday approved Pfizer Inc.'s drug Sutent to treat two deadly cancers, providing a boost for the beleaguered drug giant and offering more promise for a burgeoning approach in fighting tumors.
Sutent, a once-a-day-pill, was approved to treat advanced kidney cancer, for which there are few remedies, and a rare stomach cancer that fails to respond to Novartis AG's blockbuster cancer drug Gleevec. It marked the first time the FDA has approved a drug for two different cancers on the same day.
Pfizer says it expects the average price per six-week treatment cycle with Sutent to be about $4,000 and the yearly cost to be about $38,000. The drug is expected to be available to patients on Feb. 3.
"Victory is sweet, and it's been a great day for us across the board," says John LaMattina, president of research and development at Pfizer. Sutent is the first cancer drug developed by Pfizer to be approved by the FDA. The experimental medicine was acquired through Pfizer's purchase of Pharmacia Corp. three years ago.
Sutent is one of a new group of targeted therapies that attack tumor cells by disrupting the signals that enable them to multiply. Gleevec was among the first such treatments and helped launch what oncologists hope will be an effective strategy for stanching tumors and prolonging survival of cancer patients with fewer side effects than those that accompany conventional chemotherapy. Sutent goes a step further: It inhibits the growth of blood vessels that feed tumors and allow them to spread to other parts of the body.
"This proves that Gleevec wasn't some lucky one-off," says George Demetri, a researcher at Dana-Farber Cancer Institute who led the study that resulted in the approval of the drug to treat the stomach cancer known as GIST, for gastrointestinal stromal tumor. "Here we have solid evidence that you can take research about the mechanisms underlying the signals that affect tumors, develop drugs to shut down those signals and help patients."
The FDA allowed both uses of Sutent based on results that didn't include extensions of patients' survival. Indeed, the drug doesn't cure either cancer. For GIST, approval was based on evidence that when patients took Sutent, the growth of their tumors was slowed. The time to progression of the tumors was 27 weeks, compared with six weeks for those who didn't take the drug. Approval for use for kidney cancer was based on patients' tumors shrinking by at least 50% -- a result that occurred in 26% of patients in one study and 37% in another, the agency said.
The immediate market appears to be small. About 32,000 new cases of kidney cancer and 5,000 GIST cancers are diagnosed each year, according to the American Cancer Society. But cancer doctors routinely try approved treatments for so-called off-label uses. Sutent is also being tested as a treatment for breast cancer, colon cancer and a form of pancreatic cancer, among others.
"The fact that it got approved for two very different, very difficult-to-treat solid tumors on the same day makes us fairly optimistic about future research," says Dana-Farber's Dr. Demetri.
The agency said the most common side effects were diarrhea, skin discoloration, mouth irritation, weakness and altered sense of taste. The agency said the drug is given orally, 50 milligrams a day for four weeks, followed by a two-week break.
The FDA's approval of the kidney-cancer use was an "accelerated approval," which means that Pfizer will return to the agency with further results demonstrating the drug's effectiveness.
The FDA has come under fire from companies over their perception that the agency is taking a cautious approach on drug approvals in the wake of questions over drug safety. It underlined the news of the approval by holding a press conference and emphasizing its quick action in a press release. Pfizer filed for approval last August. "I really believe this is an advance," says Richard Pazdur, director of the FDA's office of oncology drug products.
For Pfizer, the progress in cancer and diabetes drugs provides support for some of its highest-risk research projects. Exubera was delayed for years in both the U.S. and Europe over worries the drug might damage breathing capacity with long-term use.
Pfizer aims to become a major supplier of cancer treatments, which are highly profitable and require less spending on sales and marketing than drugs prescribed by primary-care doctors. The company already sells some cancer drugs that it acquired through Pharmacia, including Aromasin and Ellence for breast cancer and Camptosar for colorectal cancer.
Write to Scott Hensley at scott.hensley@wsj.com, Ron Winslow at ron.winslow@wsj.com and Anna Wilde Mathews at