A Pfizer leukemia drug that has been approved in adults for more than a decade will soon be available for kids 1 year and older.
Amber Specialty Pharmacy announces today that they will begin dispensing 13 Pfizer oncology products. The pharmacy’s comprehensive service model will support patients, caregivers, and oncology specialists throughout the country. Their Oncology Center of Excellence provides an enhanced level of care throughout a patient’s treatment journey.
EAST HANOVER, N.J., Dec. 8, 2020 /PRNewswire/ -- Detailed results from the Phase III ASCEMBL study demonstrate that, at 24 weeks, asciminib (ABL001) – a novel investigational treatment specifically targeting the ABL myristoyl pocket (STAMP) – nearly doubled the major molecular response (MMR) rate compared to Bosulif® (bosutinib)* (25.5% vs. 13.2%, respectively ([95% CI, 2.19-22.3]; 2-sided P=0.029) in patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) previously treated with two or more tyrosine-kinase inhibitors (TKIs)1. These data were presented today at a late-breaking abstracts session during the 62nd American Society of Hematology Annual Meeting & Exposition (ASH).
Novartis announced that, at primary analysis, the phase III ASCEMBL study met its primary endpoint of statistically significant superiority in major molecular response (MMR) rate at 24 weeks for asciminib (ABL001) vs. bosutinib. The study evaluates asciminib – a novel investigational treatment specifically targeting the ABL myristoyl pocket (STAMP) – in adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) previously treated with two or more tyrosine-kinase inhibitors (TKIs). Patients with failure or intolerance to the most recently administered TKI therapy were included in the trial.
FDA Confirms Paragraph IV Patent Challenge of Bosulif 203341 (Bosutinib) Tablets
List of Paragraph IV Patent Certifications (PPIV) as of December 3, 2018
Biogen and Ionis Pharmaceutical have entered into a new collaboration agreement to identify new antisense oligonucleotide drug candidates for the treatment of spinal muscular atrophy (SMA). Biogen will have the option to license therapies arising out of this collaboration and will be responsible for their development and commercialization.
Avillion LLP, a drug development company focused on the co-development and financing of pharmaceutical candidates from proof-of-concept through to regulatory approval, announces that the U.S. Food and Drug Administration (FDA) today approved a supplemental New Drug Application (sNDA) for Pfizer's BOSULIF® (bosutinib). The approved sNDA expands the indication for BOSULIF to include the treatment of adult patients with newly-diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML).
Pfizer and Avillion have filed applications on both sides of the Atlantic seeking to expand the treatment scope of chronic myeloid leukaemia therapy Bosulif.
Pfizer Inc. (NYSE:PFE) and Avillion LLP today announced that a supplemental New Drug Application (sNDA) for BOSULIF® (bosutinib) has been accepted for filing and granted Priority Review by the U.S. Food and Drug Administration (FDA). If approved, the sNDA would expand the approved use of BOSULIF to include patients with newly diagnosed chronic phase Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML). BOSULIF is currently indicated in the U.S. for the treatment of adult patients with Ph+ CML with resistance or intolerance to prior therapy. Priority Review status accelerates FDA review time from 10 months to a goal of six months from the day of acceptance of filing, and is given to drugs that may offer major advances in treatment or may provide a treatment for which no adequate therapy exists. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in December 2017.