ASH Clinical News ACN_4.4_SUPP_Digital Version | Page 9

INDICATION
• VENCLEXTA is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as
detected by an FDA-approved test, who have received at least one prior therapy.
• This indication is approved under accelerated approval based on overall response rate. Continued approval for this
indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Median DoR not yet reached with ~12-month follow-up
for patients treated with VENCLEXTA
Duration of response
19 +
2.9
months
0
3
months
6
9
12
15
18
21
24
Months
MRD negativity was achieved with VENCLEXTA in the peripheral blood
and bone marrow of select previously treated CLL patients with 17p deletion
MRD evaluation †
• 8 patients who achieved CR or CRi were evaluated for MRD
• 3 patients were MRD negative in peripheral blood and bone marrow
—3% out of intent-to-treat population
—37.5% MRD negative out of evaluated CR + CRi patients
MRD was evaluated in peripheral blood and bone marrow for patients who achieved CR or CRi, following treatment with VENCLEXTA.
†
• VENCLEXTA is the only oral
monotherapy approved for
previously treated patients
with 17p deletion CLL based
on a data set that included
MRD negativity
• MRD negativity was evaluated
using flow cytometry and
defined as having achieved <1
CLL cell in 10,000 leukocytes 2
ORR=overall response rate; CI=confidence interval; CR=complete remission; CRi=CR with incomplete marrow recovery; nPR=nodular PR; PR=partial remission;
iwCLL NCI-WG=International Workshop for CLL updated National Cancer Institute–sponsored Working Group guidelines (2008); DoR=duration of response; MRD=minimal residual disease.
Important Safety Information (Continued)
Drug Interactions
• For patients who have completed the ramp-up phase and are on
a steady daily dose of VENCLEXTA, reduce the dose by at least
75% when used concomitantly with strong CYP3A inhibitors.
Resume the VENCLEXTA dose that was used prior to initiating
the CYP3A inhibitor 2 to 3 days after discontinuation of the
inhibitor.
• Avoid concomitant use of moderate CYP3A inhibitors or P-gp
inhibitors. If an in hibitor must be used, reduce the VENCLEXTA
dose by at least 50%. Monitor patients more closely for signs of
VENCLEXTA toxicities. Resume the VENCLEXTA dose that was
used prior to initiating the CYP3A inhibitor or P-gp inhibitor 2 to
3 days after discontinuation of the inhibitor.
• Patients should avoid grapefruit products, Seville oranges, and
starfruit during treatment as they contain inhibitors of CYP3A.
• Avoid concomitant use of strong or moderate CYP3A inducers.
• Avoid concomitant use of narrow therapeutic index P-gp
substrates. If these substrates must be used, they should be
taken at least 6 hours before VENCLEXTA.
• Monitor international normalized ratio (INR) closely in patients
receiving warfarin.
References: 1. VENCLEXTA Prescribing Information; April 2016. 2. U.S. Food
and Drug Administration website. U.S. Department of Health and Human
Services. Center for Drug Evaluation and Research: Medical Review(s)/
Statistical Review(s). http://www.accessdata.fda.gov/drugsatfda_docs/
nda/2016/208573Orig1s000MedR.pdf. Review completion date, March 14,
2016. Accessed July 22, 2016.
Lactation
• Advise nursing women to discontinue breastfeeding during
treatment with VENCLEXTA.
Females and Males of Reproductive Potential
• Advise females of reproductive potential to use effective
contraception during treatment with VENCLEXTA and for at least
30 days after the last dose.
• Based on findings in animals, male fertility may be compromised
by treatment with VENCLEXTA.
a
b
VENCLEXTA [package insert]. North Chicago, IL: AbbVie Inc.
Data on file, AbbVie Inc. ABVRRTI62926.
Please see Brief Summary of full Prescribing Information
on the following page.
Learn more at VENCLEXTA.com