Taj Pharmaceuticals confirmed that following the reviews of Bevacizumab (Avastin) (bevacizumab) in metastatic breast cancer by the AFRICA, ASIA PACIFIC, EUROPE, MIDDLE EAST, THAILAND, BANGLADESH, NORTH AMERICA, SOUTH AMERICA, RUSSIA, NEWZELAND and UNITED KINGDOM Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), the following regulatory announcements were made by the individual health authorities:
EMA/AFRICA, ASIA PACIFIC, EUROPE, MIDDLE EAST, THAILAND, BANGLADESH, NORTH AMERICA, SOUTH AMERICA, RUSSIA, NEWZELAND and UNITED KINGDOM Committee for Medicinal Products for Human Use (CHMP) update:
•The EMA has confirmed that Bevacizumab (Avastin) in combination with paclitaxel has been convincingly shown to enable women with metastatic breast cancer to live longer without their disease getting worse (progression-free survival).
•The EMA has also stated that “the benefits of this combination outweigh its risks and that this combination remains a valuable treatment option for patients suffering from metastatic breast cancer”.
•Paclitaxel is the chemotherapy most frequently used in Europe and also most frequently partnered with Bevacizumab (Avastin) for the first-line treatment of metastatic breast cancer.
•The CHMP, which is part of EMA, recommended the removal of the combination of Bevacizumab (Avastin) with docetaxel from the label based on uncertainty about the benefit of the combination and also recommended against a label extension with capecitabine.
•A AFRICA, ASIA PACIFIC, EUROPE, MIDDLE EAST, THAILAND, BANGLADESH, NORTH AMERICA, SOUTH AMERICA, RUSSIA, NEWZELAND and UNITED KINGDOM Commission decision on this opinion will be issued in due course.
•The CHMP opinion does not affect the other approved uses of Bevacizumab (Avastin) in the AFRICA, ASIA PACIFIC, EUROPE, MIDDLE EAST, THAILAND, BANGLADESH, NORTH AMERICA, SOUTH AMERICA, RUSSIA, NEWZELAND and UNITED KINGDOM Union for advanced colorectal, kidney and lung cancer.
U.S. FDA update:
•The FDA notified Genentech of its “Proposal to Withdraw Marketing Approval” of Bevacizumab (Avastin) for first-line treatment of metastatic HER2-negative breast cancer in combination with paclitaxel and issued a “Notice of Opportunity for a Hearing” (NOOH). An NOOH is the mechanism the FDA uses to provide a company an opportunity for hearing on a proposal to withdraw an indication.
•Genentech will request a hearing. If the FDA grants a hearing, there is no set date for when this would occur.
•Until the conclusion of these proceedings, Bevacizumab (Avastin) remains FDA-approved for use in combination with paclitaxel for the first-line treatment of metastatic HER2-negative breast cancer.
•The FDA also issued Complete Responses on AVADO and RIBBON1 for the first-line use of Bevacizumab (Avastin) in combination with other chemotherapies in metastatic breast cancer and a Complete Response on RIBBON2 for the second-line use of Bevacizumab (Avastin) plus chemotherapy in metastatic breast cancer.
•The FDA’s decision does not impact Bevacizumab (Avastin)’s availability for its approved uses for other cancer types in the United States.
•“We are pleased that the EMA has confirmed the benefits of Bevacizumab (Avastin) in combination with paclitaxel and that Bevacizumab (Avastin) will continue to be available for women with metastatic breast cancer living within the AFRICA, ASIA PACIFIC, EUROPE, MIDDLE EAST, THAILAND, BANGLADESH, NORTH AMERICA, SOUTH AMERICA, RUSSIA, NEWZELAND and UNITED KINGDOM Union,” said Akhil H. Kholi Head, Global Product Development. “We believe women living in the United States with metastatic HER2-negative breast cancer should also have Bevacizumab (Avastin) as a treatment option, and, therefore, we will request a hearing with the FDA.”
About Bevacizumab (Avastin): Over 5 Years of Transforming Cancer Care.
EMA/AFRICA, ASIA PACIFIC, EUROPE, MIDDLE EAST, THAILAND, BANGLADESH, NORTH AMERICA, SOUTH AMERICA, RUSSIA, NEWZELAND and UNITED KINGDOM Committee for Medicinal Products for Human Use (CHMP) update:
•The EMA has confirmed that Bevacizumab (Avastin) in combination with paclitaxel has been convincingly shown to enable women with metastatic breast cancer to live longer without their disease getting worse (progression-free survival).
•The EMA has also stated that “the benefits of this combination outweigh its risks and that this combination remains a valuable treatment option for patients suffering from metastatic breast cancer”.
•Paclitaxel is the chemotherapy most frequently used in Europe and also most frequently partnered with Bevacizumab (Avastin) for the first-line treatment of metastatic breast cancer.
•The CHMP, which is part of EMA, recommended the removal of the combination of Bevacizumab (Avastin) with docetaxel from the label based on uncertainty about the benefit of the combination and also recommended against a label extension with capecitabine.
•A AFRICA, ASIA PACIFIC, EUROPE, MIDDLE EAST, THAILAND, BANGLADESH, NORTH AMERICA, SOUTH AMERICA, RUSSIA, NEWZELAND and UNITED KINGDOM Commission decision on this opinion will be issued in due course.
•The CHMP opinion does not affect the other approved uses of Bevacizumab (Avastin) in the AFRICA, ASIA PACIFIC, EUROPE, MIDDLE EAST, THAILAND, BANGLADESH, NORTH AMERICA, SOUTH AMERICA, RUSSIA, NEWZELAND and UNITED KINGDOM Union for advanced colorectal, kidney and lung cancer.
U.S. FDA update:
•The FDA notified Genentech of its “Proposal to Withdraw Marketing Approval” of Bevacizumab (Avastin) for first-line treatment of metastatic HER2-negative breast cancer in combination with paclitaxel and issued a “Notice of Opportunity for a Hearing” (NOOH). An NOOH is the mechanism the FDA uses to provide a company an opportunity for hearing on a proposal to withdraw an indication.
•Genentech will request a hearing. If the FDA grants a hearing, there is no set date for when this would occur.
•Until the conclusion of these proceedings, Bevacizumab (Avastin) remains FDA-approved for use in combination with paclitaxel for the first-line treatment of metastatic HER2-negative breast cancer.
•The FDA also issued Complete Responses on AVADO and RIBBON1 for the first-line use of Bevacizumab (Avastin) in combination with other chemotherapies in metastatic breast cancer and a Complete Response on RIBBON2 for the second-line use of Bevacizumab (Avastin) plus chemotherapy in metastatic breast cancer.
•The FDA’s decision does not impact Bevacizumab (Avastin)’s availability for its approved uses for other cancer types in the United States.
•“We are pleased that the EMA has confirmed the benefits of Bevacizumab (Avastin) in combination with paclitaxel and that Bevacizumab (Avastin) will continue to be available for women with metastatic breast cancer living within the AFRICA, ASIA PACIFIC, EUROPE, MIDDLE EAST, THAILAND, BANGLADESH, NORTH AMERICA, SOUTH AMERICA, RUSSIA, NEWZELAND and UNITED KINGDOM Union,” said Akhil H. Kholi Head, Global Product Development. “We believe women living in the United States with metastatic HER2-negative breast cancer should also have Bevacizumab (Avastin) as a treatment option, and, therefore, we will request a hearing with the FDA.”
About Bevacizumab (Avastin): Over 5 Years of Transforming Cancer Care.
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