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Amgen Gets FDA Approval for Label Expansion of Blincyto
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Amgen, Inc. (AMGN - Free Report) announced that the FDA has approved a label expansion for its leukemia immunotherapy Blincyto.
Amgen’s supplemental biologics license application (sBLA) for Blincyto to includenew data supporting the treatment of pediatric patients with Ph- relapsed or refractory B-cell precursoracute lymphoblastic leukemia (ALL) has been approved by the FDA.
The application was based on encouraging data from a phase I/II study, which exhibited that treatment with Blincyto induced complete remission in a clinically meaningful number of pediatric patients with Ph- relapsed or refractory B-cell precursor ALL.
We note that Blincyto had gained accelerated approval in the U.S. for the treatment of patients with Ph- relapsed or refractory B-cell precursor ALL in Dec 2014. It was granted conditional approval in the EU in Nov 2015 for the same indication.
Blincyto is also being developed for the treatment of non-Hodgkin's lymphoma (NHL) and has the potential to be developed for other hematologic malignancies including pediatric relapsed/refractory ALL. Blincyto became a part of Amgen’s pipeline following its Mar 2012 acquisition of biotech company, Micromet.
Meanwhile, in a separate press release, Amgen announced that it has obtained the global development and commercial rights from German pharmaceutical company Boehringer Ingelheim for phase I pipeline drug, BI 836908 (AMG 420) which is being developed for the treatment of multiple myeloma. AMG 420 was originally licensed to Boehringer Ingelheim by Micromet.
Also in a another press release, Amgen’s European partner, Servier announced its decision to exercise its option to commercialize omecamtiv mecarbil in chronic heart failure in Europe, as well in as the Commonwealth of Independent States, including Russia. Amgen is developing omecamtiv mecarbil for the treatment of heart failure in collaboration with Cytokinetics. Servier has European commercialization rights to omecamtiv mecarbil
Amgen currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Anika Therapeutics Inc. (ANIK - Free Report) , Geron Corporation (GERN - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) . All these stocks sport a Zacks Rank #1 (Strong Buy).
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Amgen Gets FDA Approval for Label Expansion of Blincyto
Amgen, Inc. (AMGN - Free Report) announced that the FDA has approved a label expansion for its leukemia immunotherapy Blincyto.
Amgen’s supplemental biologics license application (sBLA) for Blincyto to includenew data supporting the treatment of pediatric patients with Ph- relapsed or refractory B-cell precursoracute lymphoblastic leukemia (ALL) has been approved by the FDA.
The application was based on encouraging data from a phase I/II study, which exhibited that treatment with Blincyto induced complete remission in a clinically meaningful number of pediatric patients with Ph- relapsed or refractory B-cell precursor ALL.
AMGEN INC Price and Consensus
AMGEN INC Price and Consensus | AMGEN INC Quote
We note that Blincyto had gained accelerated approval in the U.S. for the treatment of patients with Ph- relapsed or refractory B-cell precursor ALL in Dec 2014. It was granted conditional approval in the EU in Nov 2015 for the same indication.
Blincyto is also being developed for the treatment of non-Hodgkin's lymphoma (NHL) and has the potential to be developed for other hematologic malignancies including pediatric relapsed/refractory ALL. Blincyto became a part of Amgen’s pipeline following its Mar 2012 acquisition of biotech company, Micromet.
Meanwhile, in a separate press release, Amgen announced that it has obtained the global development and commercial rights from German pharmaceutical company Boehringer Ingelheim for phase I pipeline drug, BI 836908 (AMG 420) which is being developed for the treatment of multiple myeloma. AMG 420 was originally licensed to Boehringer Ingelheim by Micromet.
Also in a another press release, Amgen’s European partner, Servier announced its decision to exercise its option to commercialize omecamtiv mecarbil in chronic heart failure in Europe, as well in as the Commonwealth of Independent States, including Russia. Amgen is developing omecamtiv mecarbil for the treatment of heart failure in collaboration with Cytokinetics. Servier has European commercialization rights to omecamtiv mecarbil
Amgen currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Anika Therapeutics Inc. (ANIK - Free Report) , Geron Corporation (GERN - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) . All these stocks sport a Zacks Rank #1 (Strong Buy).
Confidential from Zacks
Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>