Pfizer’s Bosulif Will Face Competitive Market In Second-Line CML
Approved by FDA Sept. 4, bosutinib will face off against two established tyrosine kinase inhibitors in the post-Gleevec treatment setting: Bristol’s Sprycel and Novartis’ Tasigna. Pfizer is highlighting Bosulif’s “distinct adverse event profile” and single-daily dosing to its advantage.
You may also be interested in...
Pfizer Bases Bosutinib U.S. Filing On One Single-Arm Phase II Trial
Pfizer’s NDA for dual Src and Abl inhibitor bosutinib in previously-treated Philadelphia chromosome-positive CML bypassed the failed first-line Phase III BELA trial. In Europe, BELA is the basis of a pending front-line CML application.
At Tofersen Panel Review, US FDA Shined A Light On Internal Differences Of Opinion
Agency’s presentations on Biogen/Ionis’ ALS drug included differing viewpoints from the statistical and clinical pharmacology teams; the transparency and emphasis on a multidisciplinary review approach may reflect lessons learned from missteps at the Aduhelm panel review in 2020.
BrainStorm’s ALS Treatment NurOwn, Filed Over Protest, Will Get US FDA Panel Review
A November 2022 refuse-to-file letter cited clinical and statistical issues for the stem cell therapy, which failed its Phase III clinical efficacy endpoint. However, BrainStorm has consistently asserted that NurOwn demonstrated benefit in patients with less advanced disease at baseline, and it is encouraged by regulatory flexibility FDA recently has shown for the neurodegenerative disease.