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Pfizer's (PFE) Besponsa Gets FDA Nod with a Boxed Warning

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Pfizer, Inc. (PFE - Free Report) announced that its leukemia candidate, Besponsa (inotuzumab ozogamicin) has been approved by the FDA, though with a boxed warning on the label.

Pfizer’s shares were down more than 1% on Thursday. So far this year, Pfizer’s shares are up 4.5%, comparing unfavorably with an increase of 13.8% for the industry.

 

Besponsa has been approved as a monotherapy for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL). The drug was approved in the EU last month.

The U.S. approval was based on data from a pivotal study, INO-VATE ALL, which demonstrated that patients treated with Besponsa showed significant improvement in complete response (81% in Besponsa arm versus 29% for chemotherapy), thereby meeting the primary endpoint. The study, however, failed to reach statistical significance in the analysis of overall survival (OS).The median OS in the Besponsa arm was 7.7 months versus 6.2 months for patients treated with chemotherapy.

Importantly, the U.S. label of the drug will include a boxed warning for hepatotoxicity i.e. liver damage, including hepatic veno-occlusive disease (VOD). The label will also have a warning related to increased risk of non-relapse mortality in patients who take the medicine post-hematopoietic stem cell transplantation (HSCT).

We remind investors that inotuzumab ozogamicin was granted Breakthrough Therapy designation in the U.S. for ALL.

Meanwhile, Pfizer boasts a strong oncology pipeline. Its key cancer candidate, Bavencio/avelumab received FDA approval for metastatic Merkel cell carcinoma (MCC) in Mar 2017 and for advanced bladder cancer in May. Bavencio is under review in the EU for MCC with a decision expected in the third quarter of 2017. Bavencio is being touted as a significant top-line driver for this New York-based pharma giant. Meanwhile, Pfizer is exploring the possibility of expanding the label of its breast cancer drug, Ibrance, into recurrent and subsequent early breast cancer as well as several non-breast cancer indications like pancreatic and head and neck cancers.

Other cancer candidates include talazoparib (advanced breast cancer) and dacomitinib (advanced lung cancer with EGFR activating mutations).

At the Q1 conference call, Pfizer had mentioned that approximately 25 to 30 drug approvals are expected over the next five years. These include around 15 products that have blockbuster potential.  

Pfizer carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Stocks to Consider

Better-ranked stocks in the pharma/biotech space include Regeneron Pharmaceuticals, Inc. (REGN - Free Report) , Sanofi (SNY - Free Report) and Gilead Sciences, Inc. (GILD - Free Report) . While Regeneron sports a Zacks Rank #1 (Strong Buy), Sanofi and Gilead have a Zacks Rank #2 (Buy).

Regeneron’s shares up 26.4% this year so far. Estimates have risen 31.3% for 2017 while that for 2018 have gone up 20.2% inthe past 30 days.

Shares of Sanofi are up 21.6% year to date while estimates for 2017 and 2018 have risen 3.4% and 0.6%, respectively, in the past 30 days.

Shares of Gilead have risen 2.6% so far this year while estimates for 2017 and 2018 have risen almost 7% and 0.9%, respectively, in the past 30 days.

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