designation. A key part of this review strategy is that the
FDA engages with those developing the investigational
therapeutic early in the clinical trials process and provides
continued guidance throughout the review period.
Progress Across the Clinical Cancer
The dedicated efforts of individuals working throughout
the biomedical research cycle power the development of the
tools that are used routinely to prevent, detect, diagnose,
and treat cancer. The number of tools in the physician’s
armamentarium increases over time, because research is
a continuous endeavor that constantly translates scientific
discoveries to new FDA-approved medical products.
In the 12 months leading up to July 31, 2015, the FDA
approved one new cancer prevention vaccine, one new
cancer screening test, and nine new anticancer therapeutics,
including four immunotherapeutics (see Table 1, p. 10).
During this period, the FDA also approved new uses
for one imaging agent and six previously approved
anticancer therapeutics, including the molecularly targeted
chemotherapeutic ibrutinib (Imbruvica).
The January 2015 FDA approval of ibrutinib for
Waldenström macroglobulinemia was the first-ever FDA
approval of a treatment for this rare and incurable type
of non-Hodgkin lymphoma. It followed earlier approvals
of ibrutinib for chronic lymphocytic leukemia and
mantle cell lymphoma, which were highlighted in the