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FDA Expands Use
of Ibrutinib for Waldenström Macroglobulinemia
The U.S. Food and Drug Administration (FDA)
approved the expanded use of ibrutinib to treat
Waldenström macroglobulinemia (WM), a rare
hematologic malignancy. The drug received a
“breakthrough therapy” designation for this
use, as well as an orphan product designation.
Approval of the new indication was based on
results from a clinical study of 63 previously
treated WM patients. Ibrutinib was orally administered to all participants in a daily 420 mg
dose until disease progression or side effects
became intolerable. Sixty-two percent of participants had their cancer shrink after treatment,
and the duration of response ranged from 2.8
months to approximately 18.8 months. The
most common side effects associated with
the drug are thrombocytopenia, neutropenia,
diarrhea, and anemia. The new WM approval
marks the fourth indication for ibrutinib; it is
also approved for mantle cell lymphoma, previously treated chronic lymphocytic leukemia
(CLL), and del(17p) CLL.
Source: FDA.gov
FDA Grants Fast Track
Designation to SGX301
SGX301 recently received fast track designation as first-line treatment of cutaneous
T-cell lymphoma (CTCL); the drug previously received orphan drug designation from
the FDA. CTCL constitutes a rare group of
non-Hodgkin lymphomas (NHLs), occurring in about 4 percent of the approximately
50,000 individuals diagnosed with NHL each
year. A protocol for a pivotal, double-blind,
randomized, placebo-controlled, multicenter
trial of approximately 120 patients has also
been cleared through the FDA.
Source: Solgenix press release
FDA Panel Recommends
First “Biosimilar” Drug
The FDA’s Oncologic Drugs Advisory Committee unanimously recommended the agency
approve the drug known as Zarzio®, a “biosimilar” version of Amgen’s hematopoietic growth
factor Neupogen® (filgrastim). Zarzio and two
other biosimilar drugs like Neupogen have
been \