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Amgen Gets EU Nod to Add Survival Data on Blincyto's Label

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Biotech major Amgen Inc. (AMGN - Free Report) announced that it has received European Commission’s (EC) approval to include overall survival (OS) data from the TOWER study on the label of its BiTE antibody, Blincyto.

Blincyto is approved for treatment of patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The TOWER study was conducted to support the conversion of Blincyto's accelerated approval to full approval. The study evaluated the efficacy of Blincyto versus standard of care (SOC) chemotherapy for the treatment of Ph- relapsed or refractory B-cell precursor ALL in adults.

Results from a late-stage study showed that median overall survival for patients on Blincyto was 7.7 months compared with 4 months for standard of care (SOC) chemotherapy.

Blincyto’s label in the United States already includes OS data from the TOWER study following the approval received from the FDA in July last year. In fact, the inclusion of the OS data has been instrumental in driving sales of the drug higher in the past two quarters. Blincyto sales surged 44% from the year-ago period to $49 million in the first quarter of 2018, reflecting a rise in demand

The inclusion of the OS data on the European label of the drug should further boost sales.

We remind investors that Pfizer Inc.’s (PFE - Free Report) Besponsa was approved for the treatment of relapsed or refractory B-cell precursor ALL in June last year in the EU, increasing competition for Blincyto.

Amgen’s shares have gained 5.8% so far this year against a 7.2% decrease registered by the industry.

 

Amgen currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the same sector include CRISPR Therapeutics AG (CRSP - Free Report) and Genomic Health Inc (GHDX - Free Report) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

CRISPR Therapeutics’ loss per share estimates narrowed 7.8% for 2018 and 9% for 2019 in the last 60 days. The stock has skyrocketed 166.7% year to date.

Genomic Health’s earnings estimates surged almost 47% for 2018 and 5.6% for 2019 in the past 60 days. The stock has soared 45.5% so far this year.

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