FDA Grants Full Approval for TIVDAK® to Treat Recurrent or Metastatic Cervical Cancer
“The full FDA approval of TIVDAK represents a significant achievement for women with recurrent and metastatic cervical cancer, reinforcing TIVDAK as a treatment option that has proven to extend survival in patients whose disease has advanced after initial treatments,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “This milestone underscores the importance of our ongoing clinical development program to assess the full potential of tisotumab vedotin as a treatment option in other indications.”
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“Phanes is very excited about partnering with Roche on this novel approach to treat patients with SCLC, LCNEC and EP-NECs,” said Rita Laeufle, MD, PhD, Chief Medical Officer (CMO) of Phanes. “DLL3 is highly expressed in SCLC, LCNEC and EP-NECs and an important target for treating these cancers. We believe
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“The VERSATILE-002 trial is evaluating Versamune® HPV + KEYTRUDA® (pembrolizumab) in patients with HPV16-positive HNSCC. Median overall survival (“mOS”) is 30 months (n=53) in first line recurrent metastatic HNSCC; Published results for immune checkpoint inhibitors are 7-18 months. The immune checkpoint inhibitor (ICI) naïve cohort (n=53) met its primary endpoint
“Mabwell (688062.SH) announced that its self-developed novel Nectin-4-targeting ADC (R&D code: 9MW2821) has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA), for the treatment of esophageal cancer. 9MW2821 was previously given Fast Track Designation (FTD) by the FDA for the treatment of advanced, recurrent,
