Celgene Revlimid Post-Market Phase III Study To Explore Lower Dose
Executive Summary
Celgene's Phase III study for its myelodysplastic syndromes therapy Revlimid will examine lower doses, the company told FDA's Oncologic Drugs Advisory Committee on Sept. 14
You may also be interested in...
Revlimid To Launch With Risk Management Plan; Restrictions Could Be Lifted
Celgene's Revlimid will launch under the risk management plan RevAssist to minimize fetal exposure, but the firm may lift the program if ongoing studies demonstrate there is no risk of teratogenicity
Magnitude Of Effect, Not Survival, Is Key To Approval For Oncologic Nexavar
Sponsors of oncology agents should select endpoints where a drug is likely to have a "magnitude of effect" instead of focusing on survival, FDA said following its Dec. 20 approval of Bayer/Onyx' kidney cancer therapy Nexavar (sorafenib)
Revlimid To Launch With Risk Management Plan; Restrictions Could Be Lifted
Celgene's Revlimid will launch under the risk management plan RevAssist to minimize fetal exposure, but the firm may lift the program if ongoing studies demonstrate there is no risk of teratogenicity