Pfizer's Leukemia Drug Gets FDA Nod In First-Line Setting

Pfizer, Inc. (NYSE:PFE) announced that the FDA has approved its leukemia drug, Bosulif in first-line setting.

We remind investors that Bosulif is currently approved for the treatment of chronic, accelerated or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in adults who are resistant or intolerant to prior therapy.

The drug is now approved for the first-line treatment of patients suffering from chronic phase Ph+ CML. Please note that Pfizer has a partnership with Avillion for Bosulif

Shares of Pfizer have risen 13.8% this year so far, comparing unfavorably with a 17.3% increase for the industry.

The supplemental New Drug Application (sNDA) filed by Pfizer for the label expansion was granted priority review by the FDA in August. The sNDA filing was based on data from a phase III study (BFORE). In December last year, Pfizer and Avillion announced that the study had met the primary endpoint, demonstrating superiority of Bosulif (bosutinib) over Novartis’ (NYSE:NVS) Gleevec.

Additionally, the European Medicines Agency (EMA) accepted a similar regulatory application for review.

Bosulif recorded revenues of $163 million, up 35% year over year. With the approval to treat newly diagnosed patients, which will expand the eligible patient population, the drug’s sales should improve further.

Bosulif’s label expansion makes it the third approval for a hematology indication in five months. Two leukemia treatments — Besponsa for relapsed/refractory acute lymphoblastic leukemia (ALL) and Mylotarg for newly diagnosed CD33-positive acute myeloid leukemia (AML) — were approved in third quarter of 2017.

Zacks Rank & Stocks to Consider

Pfizer carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the pharma/biotech sector include H. Lundbeck A/S (OTC:HLUYY) , and XOMA Corp. (NASDAQ:XOMA) . While XOMA carries a Zacks Rank #1 (Strong Buy), H. Lundbeck has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Shares of Lundbeck have risen 21.8% so far this year while 2018 earnings estimates have gone up 3.2% in the past 60 days.

While XOMA shares have skyrocketed 651% year to date, its 2018 loss estimates have narrowed almost 20% over the past 60 days.

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