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to execute the studies necessary to
win approval for new diseases, and the
definition of truthful information may
be ambiguous.
The legal decision applies only to the
second U.S. Circuit Court of Appeals in
New York, Connecticut, and Vermont,
though, and experts pointed out that the
FDA did not take issue with many of the
company’s plans, and would have permitted them if the company had consulted
regulators prior to filing the lawsuit.
Source: The New York Times, “Court forbids F.D.A. from blocking truthful promotion of drug.” August 7, 2015.
Medicare Reverses
Position, Will Pay for
Blinatumomab
Despite an earlier decision not to cover
blinatumomab, a drug used to treat
certain acute leukemias, the Centers
recommended for at least two 28-day
cycles with two weeks of no treatment
in between. A hospital stay for a portion
of these treatment cycles is required for
monitoring of side effects. Under the
new rule, Medicare announced that it
will also now allow an add-on technology to hospitals for this drug under the
new rule – amounting to an additional
$27,000 for the use of this drug. This
additional payment will be in place for
as many as three years, by which time
for Medicare & Medicaid Services announced it will more extensively cover
the expensive cancer drug beginning
October 1, 2015.
Blinatumomab was approved by the
U.S. FDA in December 2014 for the
treatment of Philadelphia chromosomenegative relapsed or refractory B-cell
precursor acute lymphocytic leukemia.
The drug, which is delivered via intravenous infusion, costs approximately
$178,000 per treatment course and is
T:7”
REVLIMID [lenalidomide] capsules, for oral use
Table 1: Dose Adjustments for Hematologic Toxicities for MM
The following is a Brief Summary; refer to full Prescribing Information for
complete product information.
Platelet counts
WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and
VENOUS and ARTERIAL THROMBOEMBOLISM
Embryo-Fetal Toxicity
Do not use REVLIMID during pregnancy. Lenalidomide, a thalidomide
analogue, caused limb abnormalities in a developmental monkey study.
Thalidomide is a known human teratogen that causes severe lifethreatening human birth defects. If lenalidomide is used during pregnancy,
it may cause birth defects or embryo-fetal death. In females of reproductive
potential, obtain 2 negative pregnancy tests before starting REVLIMID®
treatment. Females of reproductive potential must use 2 forms of
contraception or continuously abstain from heterosexual sex during and
for 4 weeks after REVLIMID treatment [see Warnings and Precautions
(5.1), and Med