As per recent data published in The Lancet,
) cancer drug, Afinitor (everolimus), helped reduce the tumor
size significantly in patients with non-cancerous kidney tumors.
Moreover, an absence of tumor progression was also reported.
Affecting roughly one to two million people on a worldwide
basis, these tumors are also known as renal angiomyolipomas
associated with tuberous sclerosis complex (TSC).
Afinitor is approved in the US for the treatment of adults
with renal angiomyolipomas and TSC, who do not require immediate
surgery. The drug is approved in the EU under the trade name
Votubia for the treatment of adults with renal angiomyolipoma
associated with TSC who are at risk of complications but who do
not require immediate surgery.
Votubia is also approved for the the treatment of patients (3
years and older) with subependymal giant cell astrocytoma (SEGA)
associated with TSC, who require therapeutic intervention but are
not suitable for surgery.
We note that in Jul 2012, Afinitor received approval in the EU
for the treatment of HR+ HER2- advanced breast cancer in
combination with exemestane, in postmenopausal women whose cancer
has progressed on an aromatase inhibitor.
Phase III data on Afinitor has shown that median
progression-free survival (PFS) was more than doubled in patients
treated with Afinitor plus
) Aromasin (exemestane) compared to patients on Aromasin alone.
Treatment with Afinitor improved the median PFS to 7.8 months
from 3.2 months with Aromasin ne alone.
EU approval came shortly after Novartis gained approval from
the US Food and Drug Administration (FDA) for Afinitor in
advanced breast cancer with exemestane, after the failure of
treatment with Femara (letrozole) or
) Arimidex (anastrozole).
Afinitor generated sales of $524 million in the first nine
months of 2012, up 82% year over year. The strong growth was
mainly due to its approval in advanced breast cancer. Novartis
projects incremental sales of around $1 billion for this new
We are pleased with Novartis' progress with the expansion of
Afinitor's indications. We have a Neutral recommendation on
Novartis as of now. Novartis currently carries a Zacks Rank #2
Other pharma stocks which currently look attractive are
Johnson & Johnson
ASTRAZENECA PLC (AZN): Free Stock Analysis
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JOHNSON & JOHNS (JNJ): Free Stock Analysis
NOVARTIS AG-ADR (NVS): Free Stock Analysis
PFIZER INC (PFE): Free Stock Analysis Report
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