March 2025, Vol 2, No 3

Acalabrutinib (Calquence; AstraZeneca) with bendamustine and rituximab has been greenlit for adults with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem-cell transplantation (HSCT). Officials with the FDA also granted traditional approval to acalabrutinib as a single agent for adults with previously treated MCL. Read More ›

Officials with the FDA have approved nivolumab and hyaluronidase-nvhy (Opdivo Qvantig; Bristol Myers Squibb) for subcutaneous injection across approved adult, solid tumor nivolumab indications as monotherapy, monotherapy maintenance following completion of combination therapy. Read More ›

Ensartinib (Ensacove; Xcovery Holdings, Inc) has been approved for use in treating adult patients with ALK-positive locally advanced or metastatic non–small cell lung cancer (NSCLC) who have not previously received an ALK inhibitor. Read More ›

Officials with the FDA have granted accelerated approval to encorafenib (Braftovi; Array BioPharma, a subsidiary of Pfizer) with cetuximab and mFOLFOX6 for patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test. Read More ›

Remestemcel-L-rknd (Ryoncil; Mesoblast), the first allogeneic bone marrow–derived mesenchymal stromal cell therapy, has been FDA-approved for steroid-refractory acute graft-versus-host disease (SR-aGVHD) in pediatric patients aged ≥2 months. Read More ›