Literature Scan
The addition of panobinostat led
to clinically meaningful increases
in complete and near-complete
response rates and duration of
response.
Infusion reactions: The incidence of infusion reactions
was 69% with the first infusion of GAZYVA. The incidence
of Grade 3 or 4 infusion reactions was 21% with 8% of
patients discontinuing therapy. The incidence of reactions
with subsequent infusions was 3% with the second 1000
mg and < 1% thereafter. No Grade 3 or 4 infusion reactions
were reported beyond the first 1000 mg infused.
Of the first 53 patients receiving GAZYVA on the trial,
47 (89%) experienced an infusion reaction. After this
experience, study protocol modifications were made to
require pre-medication with a corticosteroid, anti-histamine,
and acetaminophen. The first dose was also divided into
two infusions (100 mg on day 1 and 900 mg on day 2). For
the 45 patients for whom these mitigation measures were
implemented, 21 patients (47%) experienced a reaction
with the first 1000 mg and < 2% thereafter [see Dosage and
Administration (2)].
Neutropenia: The incidence of neutropenia reported as an
adverse reaction was 40% in the GAZYVA treated arm and
18% in the chlorambucil alone arm with the incidence of
serious adverse events being 1% and 0%, respectively
(Table 3). Cases of l FR