^
Association details:
| Biomarker: | No biomarker |
|---|---|
| Cancer: | Urothelial Cancer |
| Drug: | Keytruda (pembrolizumab) (PD1 inhibitor) + Padcev (enfortumab vedotin-ejfv) (Microtubule inhibitor, Nectin-4-targeted antibody-drug conjugate) |
| Direction: | Sensitive |
Evidence:
Source:
Published date:
12/15/2023
Excerpt:
PADCEV is a Nectin-4-directed antibody and microtubule inhibitor conjugate indicated...in combination with pembrolizumab for the treatment of adult patients with locally advanced or metastatic urothelial cancer.
Source:
Title:
FDA grants accelerated approval to enfortumab vedotin-ejfv with pembrolizumab for locally advanced or metastatic urothelial carcinoma
Published date:
04/03/2023
Excerpt:
On April 3, 2023, the Food and Drug Administration granted accelerated approval to enfortumab vedotin-ejfv (Padcev, Astellas Pharma) with pembrolizumab (Keytruda, Merck) for patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy.
Source:
Title:
FDA Grants Priority Review for Supplemental Biologics License Application (sBLA) of PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer
Published date:
11/30/2023
Excerpt:
Astellas Pharma...and Seagen...announced that on November 30, 2023 the U.S. Food and Drug Administration (FDA) accepted for priority review a supplemental Biologics License Application (sBLA) for PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) as a combination therapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC), a form of bladder cancer that has spread to surrounding organs or muscles, or other parts of the body.
Source:
Title:
Merck Announces Phase 3 KEYNOTE-A39/EV-302 Trial Met Dual Primary Endpoints of Overall Survival (OS) and Progression-Free Survival (PFS) in Certain Patients With Previously Untreated Locally Advanced or Metastatic Urothelial Cancer
Published date:
09/22/2023
Excerpt:
Merck...announced positive topline results from the Phase 3 KEYNOTE-A39 trial (also known as EV-302), which was conducted in collaboration with Seagen and Astellas, evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv) versus chemotherapy (gemcitabine plus cisplatin or carboplatin) in patients with previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC)....In the trial, KEYTRUDA in combination with enfortumab vedotin met its dual primary endpoints of overall survival (OS) and progression-free survival (PFS), demonstrating a statistically significant and clinically meaningful improvement versus chemotherapy in patients with previously untreated la/mUC.
Trial ID:
