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     124  0 Kommentare Seagen and Genmab Announce FDA Accelerated Approval for TIVDAK (tisotumab vedotin-tftv) in Previously Treated Recurrent or Metastatic Cervical Cancer - Seite 2

    “We are thrilled to see this new treatment approved by the FDA. We are grateful to have another option for this devastating disease,” said Tamika Felder, Founder, Cervivor.

    “We are pleased with the accelerated approval of TIVDAK, Seagen’s third FDA-approved antibody-drug conjugate, and fourth approved medicine. Our mission at Seagen is to develop medicines that make a difference for people impacted by cancer,” said Roger Dansey, M.D., Chief Medical Officer, Seagen.

    “TIVDAK’s approval as a monotherapy in the U.S. is an important milestone for women with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy, as they are in need of a new treatment option and we look forward to making it available to them,” said Jan van de Winkel, Ph.D., Chief Executive Officer, Genmab. “The journey towards the approval of TIVDAK started nearly two decades ago with innovative research by scientists at Genmab and Seagen and reflects on our purpose of making an impact in the lives of cancer patients and their families. Today’s announcement marks Genmab’s evolution into a fully integrated biotechnology company and we would like to thank patients, caregivers, investigators and our collaborators for their participation in our clinical studies.”

    The Biologics License Application (BLA) for TIVDAK was submitted in February 2021 and accepted with Priority Review in April 2021. The submission was based on the results of the innovaTV 204 trial.

    The FDA’s Accelerated Approval Program allows for approval of a medicine based on a surrogate endpoint that is reasonably likely to predict clinical benefit, if the medicine fills an unmet medical need for a serious condition. A global, randomized phase 3 clinical trial (innovaTV 301) is underway and is also intended to support global registrations.

    About Cervical Cancer

    It is estimated that in 2021, more than 14,480 new cases of invasive cervical cancer will be diagnosed in the U.S., and 4,290 women will die from the disease.2 Cervical cancer remains one of the leading causes of cancer death in women globally, with over 311,000 women dying of the disease in 2018.3

    About the innovaTV 204 Trial

    The innovaTV 204 trial (NCT03438396/GOG-3023/ENGOT-cx6) is an open-label, multicenter, single-arm phase 2 trial that evaluated tisotumab vedotin in 101 patients with recurrent or metastatic cervical cancer who had received no more than two prior systemic regimens in the recurrent or metastatic setting, including at least one prior platinum-based chemotherapy regimen. Patients were excluded if they had active ocular surface disease, any prior episode of cicatricial conjunctivitis or Stevens-Johnson syndrome, Grade ≥2 peripheral neuropathy or known coagulation defects leading to an increased risk of bleeding. The main efficacy outcome measures were confirmed ORR per RECIST v1.1 as assessed by an IRC and DOR.1

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    Seagen and Genmab Announce FDA Accelerated Approval for TIVDAK (tisotumab vedotin-tftv) in Previously Treated Recurrent or Metastatic Cervical Cancer - Seite 2 Seagen Inc. (Nasdaq: SGEN) and Genmab A/S (Nasdaq: GMAB) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to TIVDAK (tisotumab vedotin-tftv), the first and only approved antibody-drug conjugate (ADC) …