CLINICAL NEWS
Latest & Greatest
FDA Approves First
Biosimilar Drug
Zarxio (filgrastim-sndz), a biosimilar product of filgrastim, was recently approved by
the U.S. Food and Drug Administration
(FDA). This is the first biosimilar drug – a
biological product that is approved based
on demonstrations that it is highly similar
to an already-approved biological product,
known as the reference product – to receive
approval. Filgrastim-sndz is approved for
all of the indications of the reference product, which was initially licensed in 1991.
The FDA’s approval of filgrastim-sndz is
based on review of evidence that included
structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data,
clinical immunogenicity data, and other
clinical safety and effectiveness data that
demonstrate its similarity to the reference
product. “Biosimilars will provide access to
important therapies for patients who need
them,” said FDA Commissioner Margaret A. Hamburg, MD. “Patients and the
health-care community can be confident
that biosimilar products approved by the
FDA meet the agency’s rigorous safety, efficacy, and quality standards.”
Source: FDA News Release
FDA Expands
Indications for
Lenalidomide
Lenalidomide plus dexamethasone is now
approved for the treatment of patients with
newly diagnosed multiple myeloma. The
U.S. FDA had previously approved this
combination in June 2006 for the treatment
of patients with multiple myeloma (MM)
who had received at least one prior therapy.
The recent decision to expand the treatment’s indication was based on results from
multiple phase 3 studies, including the
randomized, open-label, three-arm FIRST
trial (MM-020/IFM 07-01). In this study,
continuous lenalidomide + dexamethasone
(Rd Continuous) until disease progression
was compared with melphalan, prednisone,
and thalidomide (MPT) administered for
18 months. Researchers also evaluated a
fixed duration of 18 cycles of lenalidomide
+ dexamethasone in 1,623 newly diagnosed patients who were not eligible for
stem cell transplant. The primary endpoint
was median progression-free survival.
Comp