To date, Teva has not received any further complaints or adverse events reports related to this recall.
Zanubrutinib is marketed under the trade name Brukinsa and is currently indicated for the treatment of mantle cell lymphoma.
Zynlonta (loncastuximab tesirine-lpyl) is a CD19-directed antibody and alkylating agent conjugate.
The FDA has approved Opdivo (nivolumab) plus chemotherapy for the first-line treatment of patients with gastric cancer.
The accelerated approval was based on data from the multicenter, open-label, phase 2 TROPHY study.
Tisotumab vedotin is an investigational antibody-drug conjugate targeted to tissue factor.
The new dosing schedule is in addition to the approved weekly dosage regimen.
The approval is supported by data from the multicenter, randomized, open-label phase 3 IKEMA trial.
Abecma is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy.
The phase 3 trial evaluated the efficacy and safety of cemiplimab in women 18 years of age and older with recurrent or metastatic cervical cancer, including those with either squamous cell carcinoma or adenocarcinoma.
