The committee voted against restricting the use of ESAs to small cell lung cancer.
Question 2--Should FDA require that product labeling be modified? Please address each of four potential approaches to mitigating risks through revised labeling separately.
a. To date, only clinical trials in small cell lung cancer have reasonably excluded an increased risk for death among patients receiving ESAs. Trials have demonstrated an increased risk of death and/or tumor promotion in head/neck, non-small cell lung cancer, breast (neoadjuvant and metastatic settings), lymphoid malignancies, and cervical cancers. Tumor types, other than those listed above, have not been adequately studied. Should the current indication be modified to restrict use only to patients with small cell lung cancer?
Vote: YES-- 6 NO-- 8
Question 2--Should FDA require that product labeling be modified? Please address the following potential approaches to mitigating risks through revised labeling.
b. Vote: The PREPARE trial demonstrated decreased relapse-free and overall survival in breast cancer patients receiving neoadjuvant chemotherapy. The risk/benefit assessment is different for patients receiving neoadjuvant and adjuvant chemotherapies than for patients with metastatic or incurable cancers. Should the current indication be modified to include a statement that ESA use is not indicated for patients receiving potentially curative treatments?
Vote: YES--11 NO--2
The current indication should be modified to say that it should not be used in the adjuvant setting.
c. Vote: Although increased tumor promotion and/or decreased survival have been demonstrated in several tumor types, adverse findings have been duplicated in two malignancies-breast cancer and head and neck cancer Should the current indication be modified to include a statement that ESA use is not indicated for patients with breast and/or head & neck cancers? (If yes, please specify breast and/or head & neck cancer).
Vote: YES--9 NO--5
Modified to say that ESA use not indicated for metastatic breast and head and neck cancers.
Question 2--Should FDA require that product labeling be modified? Please address each of four potential approaches to mitigating risks through revised labeling separately.
a. To date, only clinical trials in small cell lung cancer have reasonably excluded an increased risk for death among patients receiving ESAs. Trials have demonstrated an increased risk of death and/or tumor promotion in head/neck, non-small cell lung cancer, breast (neoadjuvant and metastatic settings), lymphoid malignancies, and cervical cancers. Tumor types, other than those listed above, have not been adequately studied. Should the current indication be modified to restrict use only to patients with small cell lung cancer?
Vote: YES-- 6 NO-- 8
Question 2--Should FDA require that product labeling be modified? Please address the following potential approaches to mitigating risks through revised labeling.
b. Vote: The PREPARE trial demonstrated decreased relapse-free and overall survival in breast cancer patients receiving neoadjuvant chemotherapy. The risk/benefit assessment is different for patients receiving neoadjuvant and adjuvant chemotherapies than for patients with metastatic or incurable cancers. Should the current indication be modified to include a statement that ESA use is not indicated for patients receiving potentially curative treatments?
Vote: YES--11 NO--2
The current indication should be modified to say that it should not be used in the adjuvant setting.
c. Vote: Although increased tumor promotion and/or decreased survival have been demonstrated in several tumor types, adverse findings have been duplicated in two malignancies-breast cancer and head and neck cancer Should the current indication be modified to include a statement that ESA use is not indicated for patients with breast and/or head & neck cancers? (If yes, please specify breast and/or head & neck cancer).
Vote: YES--9 NO--5
Modified to say that ESA use not indicated for metastatic breast and head and neck cancers.
