ASH Clinical News ACN_4.3_FULL-ISSUE-DIGITAL | Page 7

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
FOCUSED ON EFFICACY WITH DURABLE RESPONSES IN R/R MCL 1
80% ORR [95% CI: 72, 87] / 40% CR [95% CI: 31, 49] / IRC-assessed per 2014 Lugano classifi cation* /
Median DoR not reached at 15.2 month median follow-up
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
verifi cation and description of clinical benefi t in
confi rmatory trials.
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 wi th
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.
IMPORTANT SAFETY INFORMATION
Second Primary Malignancies
Hemorrhage
Second primary malignancies, including non-skin
Serious hemorrhagic events, including fatal events,
have occurred in the combined safety database of 612 carcinomas, have occurred in 11% of patients with
patients with hematologic malignancies treated with hematologic malignancies treated with CALQUENCE
CALQUENCE monotherapy. Grade 3 or higher bleeding monotherapy in the combined safety database of 612
patients. The most frequent second primary malignancy
events, including gastrointestinal, intracranial, and
was skin cancer, reported in 7% of patients. Advise
epistaxis, have been reported in 2% of patients.
protection from sun exposure.
Overall, bleeding events, including bruising and
petechiae of any grade, occurred in approximately
Atrial Fibrillation and Flutter
50% of patients with hematological malignancies.
In the combined safety database of 612 patients with
The mechanism for the bleeding events is not
hematologic malignancies treated with CALQUENCE
well understood.
monotherapy, atrial fi brillation and atrial fl utter of
any grade occurred in 3% of patients, and Grade 3
CALQUENCE may further increase the risk of
in 1% of patients. Monitor for atrial fi brillation and
hemorrhage in patients receiving antiplatelet or
atrial fl utter and manage as appropriate.
anticoagulant therapies, and patients should be
monitored for signs of bleeding.
ADVERSE REACTIONS
Consider the benefi t-risk of withholding CALQUENCE The most common adverse reactions (≥20%) of any
for 3 to 7 days pre- and post-surgery, depending
grade were anemia,* thrombocytopenia,* headache
upon the type of surgery and the risk of bleeding.
(39%), neutropenia,* diarrhea (31%), fatigue (28%),
Infection
myalgia (21%) and bruising (21%).
Serious infections (bacterial, viral, or fungal), including *Treatment-emergent decreases (all grades) of
fatal events and opportunistic infections, have occurred hemoglobin (46%), platelets (44%), and neutrophils
in the combined safety database of 612 patients with
(36%) were based on laboratory measurements and
hematologic malignancies treated with CALQUENCE
adverse reactions.
monotherapy. Grade 3 or higher infections occurred in The most common Grade ≥3 non-hematological
18% of these patients. The most frequently reported
adverse reaction (reported in at least 2% of patients)
Grade 3 or 4 infection was pneumonia. Infections due
was diarrhea (3.2%).
to hepatitis B virus (HBV) reactivation and progressive
Dosage reductions or discontinuations due to any
multifocal leukoencephalopathy (PML) have occurred.
adverse reaction were reported in 1.6% and 6.5% of
Monitor patients for signs and symptoms of infection
patients, respectively.
Please see Brief Summary of complete Prescribing Information on adjacent pages.
CALQUENCE is a registered trademark of the AstraZeneca group of companies ©2017 AstraZeneca. All rights reserved. US-12327 11/17
Increases in creatinine 1.5 to 3 times the upper limit
of normal occurred in 4.8% of patients.
DRUG INTERACTIONS
Strong CYP3A Inhibitors: Avoid co-administration
with a strong CYP3A inhibitor. If a strong CYP3A inhibitor
will be used short-term, interrupt CALQUENCE.
Moderate CYP3A Inhibitors: When CALQUENCE is
co-administered with a moderate CYP3A inhibitor,
reduce CALQUENCE dose to 100 mg once daily.
Strong CYP3A Inducers: Avoid co-administration
with a strong CYP3A inducer. If a strong CYP3A inducer
cannot be avoided, increase the CALQUENCE dose to
200 mg twice daily.
Gastric Acid Reducing Agents: If treatment with a
gastric acid reducing agent is required, consider using an
H2-receptor antagonist or an antacid. Take CALQUENCE
2 hours before taking an H2-receptor antagonist.
Separate dosing with an antacid by at least 2 hours.
Avoid co-administration with proton pump inhibitors.
Due to the long-lasting effect of proton pump inhibitors,
separation of doses may not eliminate the interaction
with CALQUENCE.
SPECIFIC POPULATIONS
There is insuffi cient clinical data on CALQUENCE
use in pregnant women to inform a drug-associated
risk for major birth defects and miscarriage. Advise
women of the potential risk to a fetus.
It is not known if CALQUENCE is present in human
milk. Advise lactating women not to breastfeed while
taking CALQUENCE and for at least 2 weeks after the
fi nal dose.
* Tumor response was assessed according to the Lugano classifi cation for
non-Hodgkin’s lymphoma (NHL).
CR=complete response; DoR=duration of response; IRC=Independent Review
Committee; ORR=overall response rate (defi ned as the proportion of patients
who achieved a CR or PR); PR=partial response; R/R=relapsed/refractory.
Reference: 1. CALQUENCE [package insert]. Wilmington, DE:
AstraZeneca Pharmaceuticals LP; 2017.
VISIT CALQUENCE.COM