) received approval for another oncology candidate recently.
Bosulif (bosutinib) gained US Food and Drug Administration (FDA)
approval for the treatment of chronic, accelerated, or blast phase
Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia
(CML) in adult patients who are resistant or intolerant to prior
Bosulif enjoys orphan drug status in the US. According to the
American Cancer Society, more than 5,000 new cases of chronic
myelogenous leukemia, which is one of the four most common types of
leukemia, are diagnosed annually in the US.
Treatments approved for different kinds of chronic myelogenous
) Gleevec and Tasigna and
Pfizer has been making significant progress with its oncology
pipeline. Bosulif is the third candidate in Pfizer's oncology
pipeline to gain US approval in the last thirteen months.
Meanwhile, Pfizer also gained European Commission (EC) approval
for its renal cell cancer drug, Inlyta (axitinib). Inlyta gained
approval from the EC for use in treatment-failed patients (prior
treatment with Sutent (sunitinib or a cytokine) with advanced renal
cell carcinoma (RCC).
Approval was largely expected as earlier this year the Committee
for Human Medicinal Products (CHMP) of the European Medicines
Agency (EMA) had issued a positive opinion regarding Inlyta. The EU
approval of Inlyta will provide advanced renal cell carcinoma
patients, especially previously-treated patients, with an
additional treatment option. We note that Inlyta gained approval
earlier this year in the US. Other countries where Inlyta is
already approved include Switzerland, Japan, Canada, Australia, and
Korea. Pfizer is currently conducting a phase III study with Inlyta
in treatment-naïve patients suffering from renal cell carcinoma.
Besides Inlyta, Pfizer has two drugs approved for kidney cancer -
Sutent and Torisel.
We currently have a Neutral recommendation on Pfizer, which
carries a Zacks #3 Rank (short-term Hold rating). While near-term
earnings will be driven by cost cutting efforts and share
repurchases, longer-term growth will depend on the success of drug
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