Tag Archives: Blincyto

April, 2018

2 April
FDA Approves Amgen’s Blincyto to Treat Minimal Residual Disease-Positive B-Cell Precursor Acute Lymphoblastic Leukemia

THOUSAND OAKS, Calif., March 29, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for BLINCYTO® (blinatumomab) for the treatment of adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater …
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30 March
FDA Grants Priority Review to Amgen’s Blincyto sBLA

THOUSAND OAKS, Calif., March 29, 2017 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for BLINCYTO® (blinatumomab) to include overall survival (OS) data from the Phase 3 TOWER study. The application also includes new …
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2 September
FDA Approves Amgen’s Blincyto for Treatment of Pediatric Patients with Rare Form of Leukemia

THOUSAND OAKS, Calif., Sept. 1, 2016 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for BLINCYTO® (blinatumomab) to include new data supporting the treatment of pediatric patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor …
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27 July
Cytokinetics and Astellas Expand Collaboration into ALS

SOUTH SAN FRANCISCO, Calif. and TOKYO, July 27, 2016 (GLOBE NEWSWIRE) — Cytokinetics, Inc.(Nasdaq:CYTK) (“Cytokinetics”) and Astellas Pharma Inc. (TSE:4503) (“Astellas”) today announced that Cytokinetics and Astellas have expanded their collaboration in skeletal muscle activators to include amyotrophic lateral sclerosis (ALS). Through this expansion, Cytokinetics has granted Astellas an option …
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10 June
Amgen’s Blincyto Improved Overall Survival in Patients with B-Cell Precursor ALL

THOUSAND OAKS, Calif., June 10, 2016 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced new data from a prespecified interim analysis of the Phase 3 TOWER study, in which BLINCYTO® (blinatumomab) demonstrated an almost two-fold increase in median overall survival (OS) compared to standard of care (SOC). The randomized, open-label TOWER …
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4 May
Amgen’s sBLA for Blincyto Granted FDA Priority Review for Certain ALL Patients

THOUSAND OAKS, Calif., May 3, 2016 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for BLINCYTO® (blinatumomab) to include new data supporting the treatment of pediatric and adolescent patients with Philadelphia chromosome‑negative (Ph-) …
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5 February
Amgen’s Blincyto Meets Primary Endpoint in Late-Stage ALL Study

THOUSAND OAKS, Calif., Feb. 4, 2016 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the results of a prespecified interim analysis showed that the primary endpoint of improved overall survival was met in the Phase 3 TOWER study. The randomized, open-label TOWER study evaluated the efficacy of BLINCYTO® (blinatumomab) versus standard of care …
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4 December
Amgen and Merck Enter Cancer Immunotherapy Collaboration for NHL

THOUSAND OAKS, Calif. and KENILWORTH, N.J., Dec. 4, 2015 /PRNewswire/ — Amgen (NASDAQ: AMGN) and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced a cancer immunotherapy collaboration to support a Phase 1b/3 study investigating BLINCYTO® (blinatumomab) in combination with KEYTRUDA® (pembrolizumab) in patients with diffuse large …
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