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Pfizer's Leukemia Candidate Gets Priority Review From FDA

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Pfizer, Inc (PFE - Free Report) announced that the FDA has granted a priority review to its new drug application (NDA) filed for the pipeline candidate glasdegib.

Pfizer is looking to get glasdegib approved for the first-line treatment of acute myeloid leukemia (AML) in combination with a chemotherapy treatment with respect to patients, ineligible for intensive chemotherapy.

Data from the phase II BRIGHT 1003 study showed that glasdegib, an oral smoothened inhibitor, led to a significant improvement in overall survival when added to low-dose cytarabine (LDAC) in comparison to LDAC alone in previously untreated patients with AML or high-risk myelodysplastic syndrome, who were ineligible for intensive chemotherapy. The findings from the study were presented at the 58th American Society of Hematology in 2016.

The FDA has set a Prescription Drug User Fee Act or PDUFA goal date in December 2018.

Earlier this year, Pfizer enrolled in a phase III BRIGHT AML 1019 trial (NCT03416179), evaluating glasdegib as an intensive/non-intensive chemotherapy on patients with newly diagnosed AML.

Per the company’s press release, AML, a rapidly progressing blood cancer, represents a market with huge demand for new treatment options.

Shares of Pfizer have inched up 0.3% year to date against the industry’s decline of 6.2%.


Pfizer currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the Large Cap Pharma and Biotech sectors are H Lundbeck A/S (HLUYY - Free Report) , CRISPR Therapeutics AG (CRSP - Free Report) and Genomic Health Inc (GHDX - Free Report) , all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

H Lundbeck’s earnings estimates have been revised 11.6% upward for 2018 and 4.3% for 2019 in the past 60 days. The stock has surged 34.1% year to date.

CRISPR Therapeutics’ loss per share estimates has been narrowed by 7.8% for 2018 and 9% for 2019 in the last 60 days. The stock has skyrocketed 150.4% year to date.

Genomic Health’s earnings estimates have been raised 46.9% for 2018 and 5.6% for 2019 in the past 60 days. The stock has soared 46.2% so far this year.

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