US FDA grants full approval for Pfizer`s cervical cancer drug
Company Announcement Full approval based on global Phase 3 study demonstrating overall survival benefit of TIVDAK compared to chemotherapyTIVDAK is the first antibody-drug conjugate in this patient...
TIVDAK sBLA Application Accepted for Priority Review by FDA for Cervical Cancer
Media Release COPENHAGEN, Denmark; January 9, 2024 TIVDAK sBLA accepted for priority review, FDA action date is May 9, 2024Submission based on positive results from global phase 3 innovaTV 301...
Media Release TIVDAK demonstrated statistically significant overall survival, progression-free survival and objective response rate compared to chemotherapy in late-breaking results presented at...
Company Announcement Phase 3 innovaTV 301 confirmatory trial met its primary endpoint of improved overall survival (OS) at predetermined, independent interim analysisTrial results to be submitted for...
COPENHAGEN, Denmark & BOTHELL, Wash.--(BUSINESS WIRE)--Genmab A/S (Nasdaq: GMAB) and Seagen Inc. (Nasdaq: SGEN) today announced interim data from the innovaTV 205 trial, which included data evaluating tisotumab vedotin (TIVDAK®) in combination with pembrolizumab (Cohort E) in patients with recurrent or metastatic cervical cancer (r/mCC) who have not received prior systemic therapy, with a confirmed objective response rate (ORR) of 41% (95% Confidence Interval [CI]: 24% to 59%) and median durability of response that was not reached within almost 19 months of median follow up. Data were presented during an oral session at the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting on June 6.
COPENHAGEN, Denmark & BOTHELL, Wash.--(BUSINESS WIRE)--Genmab A/S (Nasdaq: GMAB) and Seagen Inc. (Nasdaq: SGEN) will present preliminary data from the innovaTV 207 global, open-label, multicenter phase 2 trial of tisotumab vedotin (TIVDAK®) as a monotherapy in patients with squamous cell carcinoma of the head and neck (SCCHN) who experienced disease progression on or after a first-line platinum-containing regimen and a checkpoint inhibitor. Early results showed tisotumab vedotin demonstrated a manageable safety profile and promising preliminary antitumor activity in this patient population with the primary endpoint of confirmed objective response rate (ORR) per investigator, achieved by 16 percent of patients (95% CI: 5.5 to 33.7). Findings will be presented as part of a plenary session at the American Society for Radiation Oncology (ASTRO) 2022 Multidisciplinary Head and Neck Cancers Symposium on February 25.
BOTHELL, Wash.--(BUSINESS WIRE)--Seagen Inc. (Nasdaq:SGEN) today reported financial results for the fourth quarter and year ended December 31, 2021. The Company also highlighted ADCETRIS® (brentuximab vedotin), PADCEV® (enfortumab vedotin-ejfv), TUKYSA® (tucatinib) and TIVDAK® (tisotumab vedotin-tftv) commercial and development accomplishments, as well as progress across its robust oncology pipeline.
BOTHELL, Wash.--(BUSINESS WIRE)--Seagen Inc. (Nasdaq:SGEN) reported financial results today for the third quarter and nine months ended September 30, 2021. The Company also highlighted ADCETRIS® (brentuximab vedotin), PADCEV® (enfortumab vedotin-ejfv), TUKYSA® (tucatinib) and TIVDAK™ (tisotumab vedotin-tftv) commercial and development accomplishments, as well as progress across its robust oncology pipeline.