Herceptin Approved in EU for
HER2-Positive Advanced Gastric Cancer
Roche announced that the European
Commission has approved Herceptin (trastuzumab)
in combination with chemotherapy for use
in patients with HER2-positive
metastatic gastric cancer. The approval
is based on results from the
international ToGA trial, which showed
that treatment with Herceptin
significantly prolongs the lives of
patients with this aggressive cancer.
The OS for patients with high levels of
HER2 was 16 months vs. 11.8 months (on
average) for those receiving
chemotherapy alone.
“Herceptin is the first targeted
biological therapy to show a survival
benefit in advanced stomach cancer and
represents a significant advance in the
treatment of this devastating disease,”
said Pascal Soriot, Chief Operating
Officer, Roche Pharmaceutical Division.
Source:
Roche
TYKERB Receives Accelerated Approval for
1st line Combination
Treatment of HR+, HER2+/ErbB2+
Metastatic BC
GlaxoSmithKline announced that the FDA
has granted accelerated approval for a
new combination regimen using TYKERB (lapatinib)
as a 1st line treatment for
women with metastatic breast cancer
(BC). TYKERB is now indicated in
combination with letrozole for treatment
of postmenopausal women with hormone
receptor positive (HR+) metastatic BC
that overexpresses the HER2 receptor,
for which hormonal therapy is indicated.
This accelerated approval was based on
the results of a double-blind,
placebo-controlled study that enrolled
219 women diagnosed with postmenopausal,
HR+ and HER2+ metastatic BC. Women
treated with lapatinib and letrozole
experienced a 5.2-month increase in
median PFS over those treated with
letrozole alone. However, TYKERB in
combination with an aromatase inhibitor
has not been compared with a trastuzumab-containing
chemotherapy regimen for the treatment
of metastatic BC.
TYKERB is already indicated in
combination with capecitabine for
treatment of patients with advanced or
metastatic BC whose tumors overexpress
HER2 and have received prior therapy,
including an anthracycline, a taxane,
and trastuzumab.
Source:
GSK
FDA Approves Rituxan plus Chemotherapy
for CD20-positive CLL
Genentech and Biogen Idec announced that
the FDA has approved Rituxan (rituximab)
in combination with fludarabine and
cyclophosphamide (FC) for people with
previously untreated and previously
treated CD20-positive chronic
lymphocytic leukemia (CLL).
The approval is based on data from two
Phase III studies, CLL8 and REACH.
Sponsored by Roche, CLL8 was a global,
multi-center, randomized, open-label,
Phase III study that enrolled 817
patients with previously untreated
CD20-positive CLL. REACH was a global,
multi-center, randomized, open-label,
Phase III study sponsored by Genentech,
Biogen Idec, and Roche, which enrolled
552 patients with previously treated
CD20-positive CLL who had not previously
received Rituxan (Rituxan-naive). Both
studies evaluated Rituxan plus FC
against FC alone. The primary endpoint
for both studies was PFS and secondary
endpoints included overall survival,
event-free survival, duration of
response, response rate, complete
response, and toxicity.
In the CLL8 study, patients who received
Rituxan plus FC had a PFS of 39.8,
compared to 31.5 months for those who
received FC alone. In the REACH study,
previously treated patients who received
Rituxan plus FC had a median PFS of 26.7
months, compared to 21.7 months for
those who received FC alone. In both
trials, PFS results were supported by a
significant increase in overall and
complete response rates.
Source:
Genentech
Tasigna Receives FDA Priority Review for
Newly Diagnosed Patients with
Early-stage CLL
Novartis announced that Tasigna (nilotinib),
a Bcr-Abl-tyrosine-kinase-inhibitor, has
been granted priority review by the FDA
for treatment of adult patients with
newly diagnosed Philadelphia
chromosome-positive chronic myeloid
leukemia (Ph+ CML) in chronic phase. In
addition to the US, regulatory
submissions have been filed in the EU
and Japan. All filings are based on data
demonstrating superior efficacy of
Tasigna in the first head-to-head
comparison with the standard of care
Glivec® in newly diagnosed Ph+ CML
patients.
The regulatory submissions are based on
data from the Evaluating Nilotinib
Efficacy and Safety in Clinical Trials
of Newly Diagnosed Ph+ CML Patients (ENESTnd)
Phase III clinical trial. This
randomized, open-label, multi-center
trial compared the efficacy and safety
of Tasigna with that of Glivec in adult
patients with newly diagnosed Ph+ CML in
chronic phase. Significantly fewer
patients progressed to more advanced
stages of the disease with Tasigna than
the standard of care Glivec (imatinib)
at 12 months. Tasigna also showed
statistically significant improvement
over Glivec in every other measure of
efficacy, including major molecular
response (MMR) and complete cytogenetic
response (CCyR), at 12 months.
Source:
Novartis
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