CLINICAL NEWS
Latest & Greatest
Hospitals Launch
Their Own Generic
Drug Company
Responding to ongoing drug short-
ages and high drug prices, several major
hospital groups in the U.S. have partnered
to form Civica Rx, a new group that will
manufacture generic drugs.
Civica Rx will produce 14 hospital-
administered generic drugs – as yet
unnamed – that often are in short supply.
When shortages of drugs occur, hospitals
may be forced to purchase drugs at price
markups or prescribe alternative treat-
ments, potentially increasing the risk to
patients.
The company hopes to remedy these
problems by creating a reliable supply of
generic drugs for its 500 hospital mem-
bers. By entering the market, Civica Rx
also intends to introduce more competi-
tion for drugs whose prices remain high.
“The mission of Civica is to make sure
these drugs remain in the public domain,
that they’re available and affordable to ev-
eryone,” said Civica Rx board chairperson
Dan Liljenquist.
Civica Rx, which was formed by three
health foundations and seven hospital
groups, plans to sell its generic drugs to
nonmember hospitals as well. The com-
pany plans to get its first products to the
market by 2019.
Sources: The Associated Press, September 6, 2018; Civica Rx press
release, September 6, 2018.
FDA Approves IV
Treatment for HCL
The U.S. Food and Drug Administra-
tion (FDA) has approved moxetumomab
pasudotox-tdfk for the treatment of adult
patients with relapsed or refractory hairy
cell leukemia (HCL) who have received at
least two prior therapies. This is the first
CD22-directed cytotoxin approved to
treat HCL.
The FDA’s decision was based on
results from a single-arm, open-label
clinical trial of 80 patients with relapsed
or refractory HCL. Participants received
moxetumomab pasudotox-tdfk 40 µg/kg
intravenously over 30 minutes on days 1,
3, and 5 of 28-day cycles, for a maximum
of six cycles or until disease progression,
unacceptable toxicity, initiation of alter-
nate therapy, or complete response (CR).
The overall response rate was 75
percent, and 30 percent of patients who
received moxetumomab pasudotox-tdfk
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achieved CR, defined as maintenance of
hematologic remission for more than 180
days. Common adverse events included
infusion-related reactions, edema, nausea,
fatigue, headache, pyrexia, constipation,
anemia, and diarrhea.
“[Moxetumomab
pasudotox-tdfk]
fills an unmet
need for patients
... whose disease
has progressed
after trying other
FDA-approved
therapies.”
—RICHARD PAZDUR, MD
“[Moxetumomab pasudotox-tdfk] fills
an unmet need for patients with hairy
cell leukemia whose disease has pro-
gressed after trying other FDA-approved
therapies,” said Richard Pazdur, MD,
director of the FDA’s Oncology Center
of Excellence and acting director of the
Office of Hematology and Oncology
Products in the FDA’s Center for Drug
Evaluation and Research.
Moxetumomab pasudotox-tdfk also
was granted fast-track, priority-review,
and orphan-drug designations.
Source: FDA press release, September 13, 2018.
Duvelisib Approved for
Patients With CLL or SLL
The FDA has approved the PI3K inhibi-
tor duvelisib for the treatment of patients
with relapsed or refractory chronic
lymphocytic leukemia (CLL) or small
lymphocytic lymphoma (SLL) who have
received at least two prior therapies.
The agency’s decision is based on
results from the randomized, multicenter,
open-label phase III DUO trial, in which
patients were treated with either oral
duvelisib 25 mg twice daily (n=95) or
intravenous ofatumumab (n=101). Com-
pared with ofatumumab, treatment
with duvelisib was associated with longer
median progression-free survival (16.4
months vs. 9.1 months; p value not
provided) and a higher overall response
rate (ORR; 78% vs. 39%; p value not
provided).
The drug also received accelerated ap-
proval for adult patients with relapsed or
refractory follicular lymphoma (FL) who
have received two prior systemic thera-
pies, based on results from the single-arm,
multicenter DYNAMO trial. Among 83
patients with FL that was refractory to
rituximab and either chemotherapy or
radioimmunotherapy, duvelisib was asso-
ciated with an ORR of 42 percent. Of the
35 patients who responded to duvelisib,
15 (43%) maintained responses for at
least 6 months and six (17%) maintained
responses for at least 12 months. The FDA
noted that continued approval for the FL
indication is contingent upon results from
a planned randomized trial.
Safety information was available for
442 patients with hematologic malignan-
cies who were treated with duvelisib at
the approved dose. Sixty-five percent
experienced serious adverse events (AEs),
most frequently infection, diarrhea or
colitis, and pneumonia. The most com-
mon any-grade AEs were diarrhea or
colitis, neutropenia, rash, fatigue, pyrexia,
cough, nausea, upper respiratory infec-
tion, pneumonia, musculoskeletal pain,
and anemia. The prescribing information
contains boxed warnings for fatal and/
or serious infections, diarrhea or colitis,
cutaneous reactions, and pneumonitis,
as well as warnings for neutropenia and
hepatotoxicity.
Source: FDA press release, September 24, 2018; Business Wire,
September 24, 2018.
Postal Service (USPS) collect information
on 70 percent of international packages
by the end of 2018, including all ship-
ments from China. This aspect is aimed at
helping the agency identify and intercept
synthetic fentanyl and other highly ad-
dictive substances imported through the
mail. USPS would be required to collect
information on 100 percent of these pack-
ages by 2020.
The package also includes the repeal
of a rule that blocks states from spending
federal Medicaid funds on addiction treat-
ment at centers with more than 16 beds,
allowing states to expand these centers’
capacities to accommodate the growing
epidemic.
The legislation also funds research for
nonopioid alternatives for pain manage-
ment and expands the ability of physicians
and nurse practitioners to prescribe bu-
prenorphine, an antiaddiction medication.
“Experts in the
field tell us that
[the funding]
is not nearly
enough. We
have to treat
[this bill] as a
starting point.”
—SEN. MAGGIE HASSAN
Sweeping Opioid
Crisis Package Signed
Into Law
On October 24, 2018, President Donald
Trump signed legislation aimed at tackling
the U.S. opioid epidemic. The package
– representing legislation passed by the
House of Representatives in June and by
the Senate in September – received biparti-
san support from the House and Senate.
The expansive package focuses on
preventing addiction before it starts and
on improving access to treatment services
for people who have become addicted to
opioids.
On the prevention side, the legislation
increases funding for law enforcement.
One measure mandates that the U.S.
Although the legislation received
bipartisan support, some critics argue that
the funding is not sufficient to reverse the
epidemic. “Experts in the field tell us that
is not nearly enough,” said Senator Maggie
Hassan (D-NH), who backed the bill. “We
have to treat this as a starting point. We
have a lot more work to do.”
Sources: The New York Times, September 26, 2018; NPR, October 24,
2018.
FDA Approves NGS-
Based Test for Patients
With ALL or MM
The FDA authorized the next-generation
sequencing (NGS)–based ClonoSEQ assay
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