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Pfizer's Leukemia Candidate Gets Priority Review in U.S.

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Pfizer Inc. PFE announced that its Biologics License Application (BLA) for leukemia candidate inotuzumab ozogamicin has been accepted for priority review by the FDA.

Inotuzumab ozogamicin is being evaluated for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

With the FDA granting priority review, a response should be out by Aug 2017.

Pfizer’s share price increased 3.5% year- to -date compared with the Zacks classified Large Cap Pharmaceuticals industry’s gain of 4.4%.

Inotuzumab ozogamicin received Breakthrough Therapy designation from the FDA in October 2015 for ALL. The submission was based on phase III study -INO-VATE ALL or Study 1022. The open-label, randomized study evaluated the safety and efficacy of the candidate, in comparison to investigator-choice chemotherapy, in adults (n=326) with relapsed or refractory CD22-positive ALL.

The study had two primary endpoints – complete response with or without hematologic remission and overall survival (OS). Data from the study revealed an improvement over chemotherapy on a number of measures that included complete hematologic remission and progression-free survival (PFS). The study met its first primary endpoint of complete response, but failed to reach statistical significance in its second primary endpoint.

However, the second primary endpoint of OS demonstrated a strong trend toward longer OS. A Marketing Authorization Application (MAA) for inotuzumab ozogamicin for the same indication is alreadyunder review in Europe.

Pfizer, Inc. Price


Pfizer, Inc. Price | Pfizer, Inc. Quote

Zacks Rank & Key Picks

Pfizer currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Sunesis Pharmaceuticals SNSS, Exact Sciences Corp. EXAS, and GlaxoSmithKline plc GSK. While Sunesis carries a Zacks Rank#1 (Strong Buy), Exact Sciences and GlaxoSmithKline carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here

Sunesis’ loss estimates narrowed by 5.06% and 8.80% for 2016 and 2017, respectively, over the past 30 days. The company recorded a positive earnings surprise in three of the last four quarters, the average being 0.54%.

GlaxoSmithKline’s earnings estimates increased from $2.64 to $2.76 for 2017 and from $2.78 to $2.85 for 2018 over the last 30 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 11.03%. Its share price increased 4.4% year to date.

Exact Sciences’ loss estimates narrowed by 1.17% and 3.57% for 2016 and 2017, respectively, over the past 60 days. The company recorded a positive earnings surprise in all of the last four quarters, the average being 14.12%.

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