ASH News Daily 2017 - Issue 1 - B-36

FDA breakthrough therapy designation

A BTK inhibitor for the
treatment of adult patients with MCL who
have received at least one prior therapy...1

CALQUENCE

GO STRONG

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FOCUSED ON EFFICACY WITH DURABLE RESPONSES IN R/R MCL1
INDICATION AND USAGE
CALQUENCE is a Bruton tyrosine kinase
(BTK) inhibitor indicated for the treatment
of adult patients with mantle cell
lymphoma (MCL) 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 conﬁrmatory trials.

The mechanism for the bleeding events
is not well understood.
CALQUENCE may further increase the
risk of hemorrhage in patients receiving
antiplatelet or anticoagulant therapies,
and patients should be monitored for
signs of bleeding.
Consider the beneﬁt-risk of withholding
CALQUENCE for 3 to 7 days pre- and
post-surgery, depending upon the type
of surgery and the risk of bleeding.
Infection
Serious infections (bacterial, viral, or
IMPORTANT SAFETY INFORMATION
fungal), including fatal events and
Hemorrhage
opportunistic infections, have occurred
Serious hemorrhagic events, including
in the combined safety database
fatal events, have occurred in the
of 612 patients with hematologic
combined safety database of 612
malignancies treated with CALQUENCE
patients with hematologic malignancies
monotherapy. Grade 3 or higher
treated with CALQUENCE monotherapy.
infections occurred in 18% of these
Grade 3 or higher bleeding events,
patients. The most frequently reported
including gastrointestinal, intracranial,
Grade 3 or 4 infection was pneumonia.
and epistaxis, have been reported in 2%
Infections due to hepatitis B virus (HBV)
of patients. Overall, bleeding events,
reactivation and progressive multifocal
including bruising and petechiae of any
grade, occurred in approximately 50% of leukoencephalopathy (PML) have
patients with hematological malignancies. occurred.

Monitor patients for signs and symptoms
of infection and treat as medically
appropriate. Consider prophylaxis in
patients who are at increased risk for
opportunistic infections.
Cytopenias
In the combined safety database of 612
patients with hematologic malignancies,
patients treated with CALQUENCE
monotherapy experienced Grade 3 or 4
cytopenias, including neutropenia (23%),
anemia (11%), and thrombocytopenia
(8%), based on laboratory measurements.
Monitor complete blood counts monthly
during treatment.
Second Primary Malignancies
Second primary malignancies, including
non-skin carcinomas, have occurred in
11% of patients with hematologic
malignancies treated with CALQUENCE
monotherapy in the combined safety
database of 612 patients. The most
frequent second primary malignancy was
skin cancer, reported in 7% of patients.
Advise protection from sun exposure.

Please see Brief Summary of complete Prescribing Information on adjacent pages.

US-14432_US-14202 Calquence ASH News Daily 2017.indd 1-2

Table of Contents for the Digital Edition of ASH News Daily 2017 - Issue 1