Breyanzi® (lisocabtagene maraleucel) – New orphan drug approval

The FDA announced the approval of Bristol-Myers Squibb Breyanzi (lisocabtagene maraleucel), for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B. February 5, 2021

Tepmetko® (tepotinib) – New drug approval

EMD Serono announced the FDA approval of Tepmetko (tepotinib), for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. February 3, 2021

Ukoniq™ (umbralisib) – New orphan drug approval

TG Therapeutics announced the FDA approval of Ukoniq (umbralisib), for the treatment of adult patients with: (1) relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen or (2) relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy. February 5, 2021

Xeljanz®, Xeljanz XR (tofacitinib) – Safety update

The FDA announced that preliminary results from a safety clinical trial show an increased risk of serious heart-related problems and cancer with Xeljanz, Xeljanz XR (tofacitinib) compared to another type of medicine called tumor necrosis factor (TNF) inhibitors. February 4, 2021