ASH Clinical News Hematology Pipeline Update: Drug Updates from the | Page 7

Idarucizumab
Lastly, Kenneth Bauer, MD, professor of medicine at Beth Israel
Deaconess Medical Center in Boston, Massachusetts, discussed
idarucizumab, a humanized monoclonal antibody fragment that
is designed to reverse dabigatran’s anticoagulant effects when
patients require emergency surgery or urgent procedures or are
experiencing episodes of uncontrolled or life-threatening bleeding
with dabigatran.
“These drugs have many characteristics that make them much
more user-friendly than vitamin K antagonists like warfarin,” Dr.
Bauer noted. “One of the issues that made physicians reluctant
to prescribe these drugs over warfarin, though, was the fact that
there were no specific reversal agents to manage bleeding associated with these oral anticoagulants.”

”All of the new drugs
coming out are going to
need biomarkers to help
us understand them, and
that’s certainly a feature
of ongoing trials.”

Dr. Lonial spoke with ASH Clinical News
about the multiple advances in multiple
myeloma, including panobinostat. Visit
ashclinicalnews.org/exclusive-videos to
watch the interview, or scan the QR code.

—SAGAR LONIAL, MD

With the approval of idarucizumab, followed by dabigatran’s
approval, based on results of the phase III REVERSE-AD trial,
Dr. Bauer commented, “We no longer need to seriously consider
prothrombin complex concentrates (PCCs), activated PCCs, or
recombinant VIIa or to employ dialysis in the management of
dabigatran-related bleeding,” he stated.
Still, there are many challenges in using reversal agents for
major or life-threatening bleeding associated with this class of
anticoagulants, such as the lack of qualitative assays for these
agents – and that the assays that are available do not return results
quickly. “Rapid point-of-care tests could be helpful in guiding
management,” Dr. Bauer said. Also, given the fact that prompt
diagnosis and administration of a reversal agent is the key to
improving outcomes when life-threatening bleeding occurs. “Will
smaller community hospitals stock these drugs, given the frequency of use and cost?”
Dr. Sekeres echoed these concerns in an interview with ASH
Clinical News, “At a large institution like Cleveland Clinic, we are
going to see these patients and we are going to stock the agent in
our main hospital. But if you’re at a smaller institution, is it worth
keeping this drug on the shelf when, eventually, it may expire and
you’ll have to absorb the cost of that drug?” ●

Watch our interview with Dr. Sekeres by
visiting ashclinicalnews.org/exclusivevideos or scanning the QR code.

February 2016

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