The Hepzato Kit (melphalan/hepatic delivery system) is approved as a liver-directed treatment for adults with metastatic uveal melanoma and unresectable hepatic metastases.
The FDA has approved Lonsurf (trifluridine/tipiracil) in combination with bevacizumab to treat previously treated metastatic colorectal cancer.
The approval was based on data from part 1 of the phase 3 RUBY trial.
The phase 3 ENHANCE study was designed to evaluate magrolimab plus azacitidine in patients with higher-risk myelodysplastic syndromes.
Vanflyta is expected to be available in the coming weeks.
A regulatory decision is expected on May 16, 2024.
The FDA has expanded the approval of Ultravist (iopromide) to include contrast-enhanced mammography to visualize known or suspected lesions of the breast in adults, as an adjunct following mammography and/or ultrasound.
Suflave is expected to be available in early August 2023.
Blincyto is supplied as a 35 mcg strength lyophilized powder for intravenous infusion after reconstitution.
The FDA has granted accelerated approval to Columvi (glofitamab) for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified or large B-cell lymphoma arising from follicular lymphoma, after 2 or more lines of systemic therapy.
