Fatal infection due to hepatitis B in patients who have not been
previously infected has been observed with Arzerra. Patients should be
monitored for clinical and laboratory signs of hepatitis.
COPENHAGEN, Denmark, April 17, 2014 (GLOBE NEWSWIRE) -- Copenhagen,
Denmark; April 17, 2014 - GlaxoSmithKline plc(LSE:GSK) and Genmab
A/S(Copenhagen:GEN)
announced today that the U.S. Food and Drug Administration (FDA) has
approved a Supplemental Biologic License Application (sBLA) for the use
of Arzerra(r) (ofatumumab), a CD20-directed monoclonal antibody, in
combination with chlorambucil for the treatment of previously untreated
patients with chronic lymphocytic leukemia (CLL) for whom
fludarabine-based therapy is considered inappropriate.1(p.1)
The FDA approval of the first-line indication is based on results from a
Phase III study (COMPLEMENT 1) which demonstrated statistically
significant improvement in median progression-free survival (PFS) in
patients who received the combination of ofatumumab and chlorambucil
compared to patients who received chlorambucil alone.1(p.16)
"CLL is the most common form of leukemia amongst adults in Western
countries, many of whom are elderly with multiple health issues," said
Dr. Paolo Paoletti, President of Oncology, GSK. "Today's approval by the
FDA for the use of Arzerra in the first-line setting means that
appropriate patients with CLL have a new treatment option."
Warnings:
WARNING: HEPATITIS B VIRUS REACTIVATION AND PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY1(p.2)
- Hepatitis B Virus (HBV) reactivation can occur in patients
receiving CD20-directed cytolytic antibodies, including Arzerra(r), in
some cases resulting in fulminant hepatitis, hepatic failure, and death.
Hepatitis B Virus Reactivation1(p.6)
Hepatitis B virus (HBV) reactivation, in some cases resulting in
fulminant hepatitis, hepatic failure and death, has occurred in patients
treated with Arzerra. Cases have been reported in patients who are
hepatitis B surface antigen (HBsAg) positive and also in patients who
are HBsAg negative but are hepatitis B core antibody (anti-HBc)
positive. Reactivation also has occurred in patients who appear to have
resolved hepatitis B infection (i.e., HBsAg negative, anti-HBc positive,
and hepatitis B surface antibody [anti-HBs] positive).
HBV reactivation is defined as an abrupt increase in HBV replication
manifesting as a rapid increase in serum HBV DNA level or detection of
HBsAg in a person who was previously HBsAg negative and anti-HBc
positive. Reactivation of HBV replication is often followed by
hepatitis, i.e., increase in transaminase levels and, in severe cases,
increase in bilirubin levels, liver failure, and death.
Hepatitis B Virus Infection1(p.7)
Fatal infection due to hepatitis B in patients who have not been
previously infected has been observed with Arzerra. Patients should be
monitored for clinical and laboratory signs of hepatitis.
Labels: Arzerra, HBV Reactivation, warning