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The nod comes for second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy.
Tivdak is an antibody-drug conjugate (ADC) that links a tissue factor-directed antibody with a payload of monomethyl auristatin E.
The agency based its review on data from the Phase II innovaTV 204 study in 101 patients, with Tivdak posting a 24% response rate, with a median duration of response of 8.3 months.
Seagen and Genmab will run a confirmatory trial to determine the drug’s clinical outcomes.
The drug will come with a black box warning for ocular toxicity, which includes a risk of changes in the corneal epithelium and conjunctiva, resulting in vision changes, including severe vision loss and corneal ulceration to the drug’s label.
Related content: Benzinga's Full FDA Calendar.
Price Action: SGEN stock closed 1.82% higher at $159.06 on Monday, while GMAB shares are up 2.93% at $44.20 during the premarket session on the last check Tuesday.
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