This phase II trial studies how well afatinib dimaleate works in treating patients with
urothelial cancer that cannot be removed surgically and has grown after treatment with
standard first-line chemotherapy. Afatinib dimaleate may turn off the function of the
epidermal growth factor (EGF) and human epidermal growth factor receptor 2 (HER2) receptors,
which may slow the growth of cancer cells or cause some of the cells to die.
This phase II trial studies how well afatinib dimaleate works in treating patients with
urothelial cancer that cannot be removed surgically and has grown after treatment with
standard first-line chemotherapy. Afatinib dimaleate may turn off the function of the
epidermal growth factor (EGF) and human epidermal growth factor receptor 2 (HER2) receptors,
which may slow the growth of cancer cells or cause some of the cells to die.
In Japan, post-approval execution of post marketing surveillance (PMS) is requested by the
Japanese Pharmaceutical Affairs Law (J-PAL) in order to accumulate safety and efficacy data
for reexamination. Reexamination period is defined by J-PAL. Eight years after approval of a
new substance, results of PMS need to be submitted as a part of reexamination dossier to the
Japanese regulatory authority, the Ministry of Health, Labour and Welfare (MHLW).
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