CLINICAL NEWS
to neurologic AEs, resulting in two and seven
treatment discontinuations, respectively.
Three deaths occurred among the study
population, of which two were reported as
potentially treatment-related.
“Continuous infusion with CD19-targeted
immunotherapy blinatumomab at various doses and schedules was feasible … and
showed anti-lymphoma activity,” Dr. Goebeler
and co-authors concluded.
The small patient population is a limitation of this study, and further studies will
have to confirm the findings among the
specific disease subtypes. Although the
stepwise dosing helped mitigate treatment
discontinuations due to neurologic AEs, nine
patients discontinued treatment, suggesting that additional strategies are needed to
curb the neurologic toxicity associated with
blinatumomab. An ongoing phase II study
is in progress to evaluate blinatumomab in
relapsed/refractory DLBCL.
REFERENCE
Goebeler ME, Knop S, Viardot A, et al. Bispecific T-cell engager (BiTE) antibody
construct blinatumomab for the treatment of patients with relapsed/refractory
non-Hodgkin lymphoma: Final results from a phase I study. J Clin Oncol. 2016
February 16. [Epub ahead of print]
T:7”
4.2 Allergic Reactions
REVLIMID is contraindicated in patients who have demonstrated
hypersensitivity (e.g., angioedema, Stevens-Johnson syndrome, toxic
epidermal necrolysis) to lenalidomide [see Warnings and Precautions
(5.8)].
5.2 REVLIMID REMS™ Program
Because of the embryo-fetal risk [see Warnings and Precautions (5.1)],
REVLIMID is available only through a restricted program under a Risk
Evaluation and Mitigation Strategy (REMS), the REVLIMID REMS™
program (formerly known as the “RevAssist®” program).
Required components of the REVLIMID REMS™ program include the
following:
• Prescribers must be certified with the REVLIMID REMS™ program by
enrolling and complying with the REMS requirements.
• Patients must sign a Patient-Physician agreement form and comply
with the REMS requirements. In particular, female patients of
reproductive potential who are not pregnant must comply with the
pregnancy testing and contraception requirements [see Use in Specific
Populations (8.6)] and males must comply with contraception
requirements [see Use in Specific Populations (8.6)].
• Pharmacies must be certified with the REVLIMID REMS™ program,
must only dispense to patients who are authorized to receive REVLI Ԕ@