Roche’s Avastin Receives EU
Approval for the Treatment of
Women with Newly Diagnosed
Advanced Ovarian Cancer
European Commission has approved
Avastin (bevacizumab) in
combination with standard
chemotherapy as a frontline
(first line following surgery)
treatment for women with
advanced ovarian cancer.
Avastin has demonstrated a
significant improvement in the
time women with ovarian cancer
live without the disease getting
worse (PFS) in three large Phase
III studies (GOG 0218 and ICON7
in the frontline setting and
OCEANS in the recurrent,
platinum-sensitive setting).
This approval will enable the
use of Avastin in combination
with carboplatin and paclitaxel
for the frontline treatment of
advanced (FIGO stages IIIB, IIIC,
and IV) epithelial ovarian,
primary peritoneal, or fallopian
tube cancer for women in Europe.
Avastin is administered in
addition to chemotherapy for up
to six cycles of treatment
followed by continued use of
Avastin as a single agent until
disease progression or for a
maximum of 15 months or until
unacceptable toxicity, whichever
occurs earlier.
Source:
Roche
US FDA Approves Pfizer’s
Axitinib for Patients with
Previously Treated Advanced RCC
Pfizer announced that the US FDA
has approved Inlyta (axitinib),
a kinase inhibitor, for the
treatment of patients with
advanced renal cell carcinoma (RCC)
after failure of one prior
systemic therapy. The approval
is based on data from the Phase
III AXIS trial, which
demonstrated that Inlyta
significantly extended (PFS)
[HR=0.67, 0.54-0.81, P<0.0001]
with a median PFS of 6.7 months
(95% CI: 6.3, 8.6) compared with
4.7 months (95% CI: 4.6, 5.6)
for those treated with sorafenib,
a current standard of care (SOC)
for this patient population,
representing a 43% improvement
in median PFS compared to
sorafenib.
Inlyta, a kinase inhibitor, is
an oral therapy that was
designed to selectively inhibit
vascular endothelial growth
factor (VEGF) receptors 1, 2 and
3,which are receptors that can
influence tumor growth, vascular
angiogenesis and progression of
cancer (the spread of tumors).
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Axitinib is also being
investigated in a randomized
clinical trial in patients with
treatment-naïve as well as
previously treated advanced RCC.
Additionally, under a
collaborative development
agreement between Pfizer and SFJ
Pharma, SFJ will conduct a Phase
III clinical trial in Asia
studying axitinib for adjuvant
treatment of patients at high
risk of recurrent RCC following
nephrectomy.
Source:
Pfizer
FDA Approves BTG’s Drug Voraxaze
for Cancer Toxicity
US
health regulators gave the nod
to a drug from British specialty
drugmaker BTG Plc that helps
cancer patients get rid of toxic
levels of a chemotherapy
treatment. The drug – called
Voraxaze – helps eliminate
methotrexate in patients whose
kidney function has been
compromised by treatment with
high doses of the chemotherapy
agent. Methotrexate is used to
treat breast, bone, and lung
cancers as well as leukemia. It
is normally eliminated from the
body by the kidneys, but
prolonged high doses of the drug
can result in kidney failure.
BTG’s injectable treatment can
quickly break down the
chemotherapy medicine and allow
the body to expel it. The FDA
granted Voraxaze orphan drug
status, meant for rare diseases
or conditions that affect a very
small portion of the population.
As incentive for companies to
develop such drugs, the orphan
designation comes with 7 years
of marketing exclusivity before
a rival medicine can be
approved.
In a clinical trial of 22
patients, Voraxaze eliminated
95% of methotrexate from blood.
For 10 of the patients,
methotrexate decreased to a low
level within 15 minutes and
stayed that way for 8 days.
Common side effects were low
blood pressure, headaches,
nausea, and vomiting.
Source:
BTG
Plc
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