Matrix 公司获得预期的FDA“未批准”信函(上)
WASHINGTON (Reuters Health) - Cancer drug maker Matrix Pharmaceutical Inc. said on Tuesday that it has received a "non-approvable" letter from the US Food and Drug Administration (FDA) regarding its new drug application (NDA) for IntraDose (cisplatin/epinephrine), a proposed treatment for malignant tumors of the head and neck.
Fremont, California-based Matrix was seeking approval of IntraDose as an alternative to systemic chemotherapy. IntraDose is an injectable gel that was designed to provide large doses of chemotherapy at the tumor site over an extended period of time.
The NDA was submitted in January 2001 and was based upon two, phase III clinical trials.
However, the non-approval was not unexpected, according to the firm.
"Matrix anticipated that the FDA would issue a non-approvable letter for IntraDose," said Matrix CEO Michael D. Casey in a statement. "We are continuing to explore with the FDA the next steps for IntraDose in the US," he added.
In September, expert advisors to the FDA voted unanimously against recommending that the agency proceed with the approval of IntraDose. The FDA's Oncologic Drugs Advisory Committee said that it was not convinced the clinical trials submitted in support of its approval showed a meaningful clinical benefit.
The FDA usually follows the recommendations of its expert advisors.
If approved, IntraDose would have been the first new drug approved for head and neck cancer in many years.
The localized chemotherapy is now also being tested as a possible treatment for primary liver cancer, a virtually unmet clinical need, as well as colorectal cancer that has spread to the liver.
Corporate officials were not immediately available to provide further details.
In Tuesday morning trading on the NASDAQ, shares of the company edged down 0.01 to 0.97. Prior to September, shares of the company had traded as high as 17.375., http://www.100md.com
Fremont, California-based Matrix was seeking approval of IntraDose as an alternative to systemic chemotherapy. IntraDose is an injectable gel that was designed to provide large doses of chemotherapy at the tumor site over an extended period of time.
The NDA was submitted in January 2001 and was based upon two, phase III clinical trials.
However, the non-approval was not unexpected, according to the firm.
"Matrix anticipated that the FDA would issue a non-approvable letter for IntraDose," said Matrix CEO Michael D. Casey in a statement. "We are continuing to explore with the FDA the next steps for IntraDose in the US," he added.
In September, expert advisors to the FDA voted unanimously against recommending that the agency proceed with the approval of IntraDose. The FDA's Oncologic Drugs Advisory Committee said that it was not convinced the clinical trials submitted in support of its approval showed a meaningful clinical benefit.
The FDA usually follows the recommendations of its expert advisors.
If approved, IntraDose would have been the first new drug approved for head and neck cancer in many years.
The localized chemotherapy is now also being tested as a possible treatment for primary liver cancer, a virtually unmet clinical need, as well as colorectal cancer that has spread to the liver.
Corporate officials were not immediately available to provide further details.
In Tuesday morning trading on the NASDAQ, shares of the company edged down 0.01 to 0.97. Prior to September, shares of the company had traded as high as 17.375., http://www.100md.com