Shots: The US FDA’s ODAC has voted 12-0 in favor of the demonstrated benefit of belantamab mafodotin monothx. outweighing the risks for patients with r/r MM prior treated with at […]readmore
Tags : Relapsed/Refractory
Shots: Y-mAbs has submitted the BLA the US FDA under the FDA’s Rolling Review process for naxitamab following the market closure on Mar 31, 2020 The BLA submission is based […]readmore
Shots: The sBLA is based on P-III CANDOR study assessing Darzalex + carfilzomib + dexamethasone (DKd) vs Kd as monothx. in 466 patients with r/r MM prior treated with 1L+ […]readmore
Shots: The BLA is based on P-III ICARIA-MM study results assessing Isatuximab in combination with pomalidomide and dexamethasone in patients with RRMM, presented at ASCO2019 and EHA 2019 Isatuximab has […]readmore
Pharma
Regulatory
Karyopharm’s Xpovio (selinexor) Receives FDA’s Accelerated Approval for Relapsed/Refractory Multiple
Shots: The accelerated approval is based P-IIb STORM study results assessing Xpovio (80mg) + dexamethasone (20mg) in 122 patients with RRMM, prior treated with 4 therapies with the refractory disease […]readmore
Shots: The P-III ICARIA-MM study results involve assessing of Isatuximab (10mg/kg, qw) + pomalidomide and dexamethasone (pom-dex) vs pom-dex in 307 patients with r/r multiple myeloma across 24 countries The […]readmore