Tag Archives: CML

December, 2017

26 December
FDA Updates Label of Novartis’ Tasigna to Include Treatment-Free Remission Data

EAST HANOVER, N.J., Dec. 22, 2017 /PRNewswire/ — Novartis announced today that the US Food and Drug Administration (FDA) approved the inclusion of Treatment-free Remission (TFR) data in the Tasigna® (nilotinib) US product label. Tasigna is now the first and only BCR-ABL tyrosine kinase inhibitor (TKI) to include data about …
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20 December
FDA Approves Pfizer’s Bosulif for the Treatment of Patients with Newly-Diagnosed Ph+ Chronic Myelogenous Leukemia

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to expand the indication for BOSULIF® (bosutinib) to include adult patients with newly-diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML). The sNDA was reviewed and approved under the …
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10 November
FDA Expands Approval of Sprycel for Children with Philadelphia Chromosome-Positive CML in Chronic Phase

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced the U.S. Food and Drug Administration (FDA) has expanded the indication for Sprycel® (dasatinib) tablets to include the treatment of children with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).1 This approval for Sprycel in pediatric patients with Ph+ CML in chronic phase was granted …
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10 July
FDA Accepts for Priority Review Bristol-Myers Squibb’s sNDA for Sprycel for Treatment of Certain Leukemia Patients

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) accepted its supplemental New Drug Application (sNDA) to include an indication for Sprycel (dasatinib) to treat children with Philadelphia chromosome-positive chronic phase (CP) chronic myeloid leukemia (CML), as well as a powder for oral suspension (PFOS) formulation …
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2 January
FDA Grants Orphan Drug Status to Escend Pharma’s ES-3000 for AML

Menlo Park, CA, December 28, 2016/PRNewswire/ — Escend Pharmaceuticals, Inc., a privately held company focused on the development of small molecule therapeutics for oncology orphan diseases, announced today that the FDA Office of Orphan Products Development (OOPD) has granted orphan drug designation for its lead product candidate, ES-3000, for the treatment …
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5 December
Pfizer’s Leukemia Drug Bosulif Proves Effective in Untreated Patients

Today, Pfizer Inc. and its partner Avillion LLP announced results from the Phase 3 BFORE (Bosutinib trial in First line chrOnic myelogenous leukemia tREatment) trial demonstrating superiority of BOSULIF® (bosutinib) over imatinib as a first-line treatment for patients with chronic phase Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML). The …
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4 December
FDA Approves Sun Pharma’s Generic Gleevec

Mumbai, December 04, 2015: Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, Sun Pharma) today announced that one of its subsidiaries has received final approval from US FDA for its Abbreviated New Drug Application (ANDA) for generic version of Gleevec®, Imatinib Mesylate tablets 100mg and …
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