New Tablet Formulation of Calquence Approved for CLL, SLL, MCL
The approval was based on data from the phase 1 ELEVATE-PLUS trials, which showed the acalabrutinib 100mg tablets were bioequivalent to the acalabrutinib 100mg capsules.
Leukemias/lymphomas/ And Other Hematologic Cancers
Omidubicel Gets Priority Review for Patients in Need of Stem Cell Transplant
Omidubicel is a first-in-class, advanced NAM (nicotinamide)-enabled stem cell therapy candidate.
COVID-19 Booster May Spur Seroconversion in Blood Cancer Patients
Among nonresponders to initial COVID-19 vaccination, seroconversion occurred in 56 percent following booster dose
Xalkori Approved for ALK-Positive Inflammatory Myofibroblastic Tumor
The approval was based on data from 2 multicenter, single-arm, open-label trials that included patients with unresectable, recurrent or refractory ALK-positive IMT.
Generic Equivalent to Istodax Now Available
Romidepsin is a histone deacetylase inhibitor indicated for the treatment of cutaneous T-cell lymphoma.
Mosunetuzumab Gets Priority Review for Advanced Follicular Lymphoma
Mosunetuzumab is a potential first-in-class CD20xCD3 T-cell engaging bispecific antibody that targets CD20 on the surface of B cells and CD3 on the surface of T cells.
FDA Warns of Increased Side Effects, Death Risk With Duvelisib
Copiktra is an oral inhibitor of phosphoinositide 3-kinase.
Breyanzi Approved as Second-Line Treatment for Large B-Cell Lymphoma
The expanded approval was based on data from the phase 3 TRANSFORM and phase 2 PILOT studies.
