Shots:

• The EC has approved Tivdak an ADC, as a monotx. for adults (n=502) with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy
• Approval was backed by P-III (innovaTV 301) global trial evaluating Tivdak vs CT alone (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed)
• The trial met its 1EP of OS, showing a 30% reduction in death risk with vs CT. Median OS was 11.5mos. v. 9.5mos. CT. 2EPs of PFS & ORR were also met, with a 33% reduction in the risk of disease progression vs CT. Data from the innovaTV 204 P-II trial evaluating Tivdak as monotx. in previously treated recurrent or metastatic cervical cancer was included in the MAA

Ref: Businesswire | Image: Genmab & Pfizer

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