MedWatch

FDA grants new Genmab drug priority review status

The US health authority FDA has accepted Genmab and Seagen's application for a biologics license application relating to their product tisotumab vedotin.

Genmab CEO Jan van de Winkel | Photo: PR / Genmab

On Friday evening, partners Genmab and Seagen announced that the US Food and Drug Administration (FDA) has accepted their biologics license application (BLA) in the US for tisotumab vedotin for treating recurrent or metastatic cervical cancer with disease progression during or after chemotherapy.

The press announcement further reads that the processing time will be accelerated, since the application was given priority review, which shortens the expected time frame with the FDA from around ten to around six months.

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