Regulatory tracker: FDA offers Pfizer’s Tivdak full nod in cervical cancer

Fierce Pharma May 1, 2024
Fraiser Kansteiner, Eric Sagonowsky, Angus Liu, Kevin Dunleavy, Zoey Becker

Welcome to 2024’s regulatory tracker for Fierce Pharma.

On this page, we’re recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Some of these updates may not make the bar for standalone stories, but we think they are still worth mentioning.

UPDATED: Wednesday, May 1 at 11:50 a.m. ET

• Pfizer and Genmab’s Tivdak has received a full approval from the FDA to treat patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Tivdak, which is among the assets Pfizer acquired in its $43 billion buyout of Seagen, notched an accelerated approval in the indication in 2021.

  Tivdak is the first antibody-drug conjugate (ADC) to show an overall survival...

Today's Sponsors

Today's Sponsor