Tivdak Approved for Recurrent or Metastatic Cervical Cancer
The approval was based on data from the phase 2 innovaTV 204 trial that evaluated Tivdak as monotherapy in 101 adult females with recurrent or metastatic cervical cancer.
Gynecologic Cancers
Pembrolizumab Plus Chemo ± Bevacizumab Prolonged Survival in Cervical Cancer
Pembrolizumab plus chemotherapy with or without bevacizumab could be a new standard of care for first-line therapy in metastatic cervical cancer.
Immunotherapy Significantly Improved Survival in Recurrent/Metastatic Cervical Cancer
The checkpoint inhibitor cemiplimab improved survival in patients with recurrent/metastatic cervical carcinoma compared with single-agent chemotherapy.
MPR Weekly Dose Podcast Episode 90
This week we have significant news on the status of a third COVID-19 vaccine booster dose, as well as news for an encephalitis vaccine, another Jardiance indication, an FDA warning concerning patient wristbands, and Jemperli gets accelerated approval.
Jemperli Gets Accelerated Approval for dMMR Recurrent or Advanced Solid Tumors
The accelerated approval was based on data from the phase 1 GARNET trial.
FDA to Review Pembrolizumab for Additional Kidney, Endometrial Cancer Indications
The sBLA submissions are supported by data from the phase 3 KEYNOTE-564 trial and the phase 2 KEYNOTE-158 trial.
Keytruda Plus Lenvima Gets Full Approval for Advanced Endometrial Cancer
The full approval was based on data from the confirmatory phase 3 KEYNOTE-775 trial.
Balstilimab Gets Priority Review for Recurrent, Metastatic Cervical Cancer
The BLA submission is based on data from a pivotal phase 2 trial that assessed balstilimab in adults with advanced cervical cancer who had relapsed or progressed after receiving first-line platinum-based chemotherapy.
Jemperli Approved for dMMR Recurrent or Advanced Endometrial Cancer
This indication is approved under accelerated approval based on tumor.
Tisotumab Vedotin Under Review for Recurrent or Metastatic Cervical Cancer
Tisotumab vedotin is an investigational antibody-drug conjugate targeted to tissue factor.
