Pfizer Inc. (PFE - Free Report) announced that the FDA has approved its once-daily oral medicine, glasdegib, for the treatment of newly-diagnosed acute myeloid leukemia (AML). The drug, to be marketed by the trade name Daurismo, is approved in combination with low-dose cytarabine (LDAC), a kind of chemotherapy treatment for patients aged 75 years and older or who cannot take intensive chemotherapy.
Daurismo was reviewed and approved under the FDA’s priority review program. Following the same, Daurismo becomes the first and the only approved Hedgehog pathway inhibitor for treating adult patients with AML. However, the drug has not been studied on patients suffering liver and severe kidney diseases.
The approval was supported by positive data from the pivotal phase II BRIGHT 1003 study. The same (n=115) evaluated Daurismo plus LDAC compared with LDAC alone. More the 50% of patients treated with the Daurismo combo experienced a reduction in the risk of death compared with those who received LDAC alone.
However, Daurismo label comes with a stern boxed warning in the United States for embryo-fetal toxicity. We would like to remind investors that this is the fourth cancer medicine nod for Pfizer in less than three months
Earlier this month, Pfizer gained the FDA’s accelerated approval for Lorbrena (lorlatinib) to treat patients with ALK-positive metastatic NSCLC, having received prior treatment with one or more ALK TKIs.
In October, the FDA approved Talzenna (talazoparib), an orally-available PARP inhibitor, which can be used for the treatment of metastatic breast cancer patients with an inherited BRCA mutation.
In September, the FDA approved Vizimpro (dacomitinib) for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients with epidermal growth factor receptor (EGFR) mutations.
In the AML space, this is the second FDA approval for Pfizer within a span of 14 months. Mylotarg was approved during the third quarter of 2017 in the United States for newly diagnosed CD33-positive AML patients.
Shares of Pfizer have rallied 18.9% so far this year, outperforming the industry’s increase of 7.5%.
Zacks Rank and Stocks to Consider
Pfizer currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the large cap pharma sector include Bristol-Myers Squibb Company (BMY - Free Report) , Johnson & Johnson (JNJ - Free Report) and Merck & Co., Inc. (MRK - Free Report) . While Bristol-Myers sports a Zacks Rank #1 (Strong Buy), J&J and Merck carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Bristol-Myers’ earnings estimates have been revised 6.9% upward for 2018 and 6.8% for 2019 over the past 60 days.
J&J’s earnings estimates have moved 0.2% north for 2018 and 0.6% for 2019 over the past 60 days. The stock has inched up 1.7% so far this year.
Merck’s earnings estimates have been raised 1.6% for 2018 and 1.7% for 2019 over the past 60 days. The stock has surged 32.9% year to date.
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