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Amgen's Leukemia Drug Blincyto Gets EU Nod for Pediatric Use

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Amgen, Inc. (AMGN - Free Report) announced that the European Commission has approved its regulatory application looking for approval of its leukemia drug, Blincyto for use in pediatric patients.

Blincyto was approved, as a monotherapy, for the treatment of Philadelphia chromosome-negative (Ph-) relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukemia (“ALL”) in pediatric patients aged one year or older. The approval was based on positive data from the phase I/II 205 study.

Amgen’s stock is up 14.8% this year so far against 3.5% decrease of its industry.

 

 

Blincyto, a BiTE immunotherapy, is already approved to treat this indication in adult patients in EU. In the United States, it is approved to treat r/r B-cell precursor ALL in adults as well as children. Meanwhile, in April, Blincyto was approved in the United States for a new indication — minimal residual disease (MRD)-positive B-cell precursor acute lymphoblastic leukemia (“ALL”).

Blincyto gained FDA approval in December 2014 and has now become a key top-line driver at Amgen while it has the potential to be developed for other hematologic malignancies.

Blincyto sales were up 25% in the United States and 73% in international markets in the first half of 2018, supported by rising demand.

Notably, in June, Amgen gained approval in EU to include overall survival (OS) data from the TOWER study on the label of Blincyto. The drug’s label in the United States was approved to include OS data from the TOWER study 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 few quarters.

Pfizer (PFE - Free Report) markets Besponsa for the treatment of relapsed or refractory B-cell precursor ALL since last year, increasing competition for Blincyto.

Amgen currently carries a Zacks Rank #3 (Hold). Some better-ranked biotech stocks include Gilead Sciences (GILD - Free Report) and Ligand Pharmaceuticals (LGND - Free Report) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Gilead’s earnings estimates increased 7.5% for 2018 and 1.9% for 2019 over the last 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 6.43%. The company’s shares have increased 5.5% year to date.

Ligand’s earnings estimates increased 14.4% for 2018 and 3.7% for 2019 over the last 60 days. The company delivered a positive earnings surprise in each of the trailing four quarters, with an average beat of 59.54%. The company’s shares have rallied 87.4% year to date.

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