Questions for the Committee

1
Questions for the Committee 1) Review of the
oncology literature suggests that there are
single agent and multiple agent therapies
capable of producing substantial response rates,
including reasonable CR rates, in relapsed,
aggressive NHL. Does the committee believe that
these therapies constitute available therapy for
relapsed, aggressive NHL previously treated with
at least two combination chemotherapy
regimens? 2) Previously, the Agency has stated
that the primary relevant endpoints
for aggressive NHL were rate of durable complete
response and survival. Partial responses were
not considered predictive of clinical benefit. In
this setting of relapsed, aggressive NHL, does
the committee agree that durable CR should
generally be the primary end point for
approval? 3) Would high rates of PR and long PR
duration be reasonably likely to predict
clinical benefit, and thus potentially support
AA? If so, please describe PR rate and
durations that would be convincing. 4) Do the
partial responses at the rate seen and for the
duration reported for Marqibo predict clinical
benefit in relapsed, aggressive NHL?