FDA approves erdafitinib for locally advanced or metastatic urothelial carcinoma

Coverage, in order

1. 5d ago
   first FDA Drug Safety / Drugs feed indie

   FDA approves erdafitinib for locally advanced or metastatic urothelial carcinoma

   On January 19, 2024, the Food and Drug Administration approved erdafitinib (Balversa, Janssen Biotech) for locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy.

2. 2d ago
   FDA Drug Safety / Drugs feed indie

   FDA grants accelerated approval to enfortumab vedotin-ejfv with pembrolizumab for locally advanced or metastatic urothelial carcinoma

   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.

3. 2d ago
   FDA Drug Safety / Drugs feed indie

   FDA approves toripalimab-tpzi for nasopharyngeal carcinoma

   FDA approves toripalimab-tpzi for nasopharyngeal carcinoma

4. 1d ago
   FDA Drug Safety / Drugs feed indie

   FDA approves nivolumab in combination with cisplatin and gemcitabine for unresectable or metastatic urothelial carcinoma

   On March 6, 2024, the Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Company) in combination with cisplatin and gemcitabine for first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC).

5. 1d ago
   FDA Drug Safety / Drugs feed indie

   FDA approves pembrolizumab with chemotherapy for unresectable advanced or metastatic malignant pleural mesothelioma

   On September 17, 2024, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) with pemetrexed and platinum chemotherapy as first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma (MPM).

6. 1d ago
   FDA Drug Safety / Drugs feed indie

   FDA approves pembrolizumab for esophageal or GEJ carcinoma

   FDA approved pembrolizumab (Keytruda, Merck Sharp & Dohme Corp.) in combination with platinum and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal carcinoma who are not candidates for surgical resection or definitive chemoradiation.

7. 1d ago
   FDA Drug Safety / Drugs feed indie

   FDA approves pembrolizumab with chemotherapy for HER2-negative gastric or gastroesophageal junction adenocarcinoma

   On November 16, 2023, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ)

8. 1d ago
   FDA Drug Safety / Drugs feed indie

   FDA approves belzutifan for advanced renal cell carcinoma

   On December 14, 2023, the Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) for patients with advanced renal cell carcinoma (RCC).

9. 1d ago
   FDA Drug Safety / Drugs feed indie

   FDA approves enfortumab vedotin-ejfv with pembrolizumab for locally advanced or metastatic urothelial cancer

   On December 15, 2023, the Food and Drug Administration (FDA) approved enfortumab vedotin-ejfv (Padcev, Astellas Pharma) in combination with pembrolizumab (Keytruda, Merck) for patients with locally advanced or metastatic urothelial cancer (la/mUC). FDA previously granted accelerated approval to this

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