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 committeebelieve that these therapies constitute
available therapy for relapsed,
aggressiveNHL previously treated with
at least two combination chemotherapy
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,