Tivdak Wins Accelerated Approval for Cervical Cancer
The FDA has granted accelerated approval to Seagen’s and Genmab’s antibody-drug conjugate Tivdak (tisotumab vedotin-tftv) for treating women with recurrent or metastatic cervical cancer whose disease has progressed during or following chemotherapy.
The approval was supported by a 101-person phase 2 trial where 24 percent of patients taking Tivdak had a positive response to treatment, with the median duration of response lasting 8.3 months.
The FDA said Tivdak must carry a boxed warning for ocular toxicity, as well as warnings for peripheral neuropathy, hemorrhage, pneumonitis and embryo-fetal toxicity.
Under the accelerated approval pathway, the companies must conduct a confirmatory trial to maintain approval.