The FDA on January 19, 2024, approved BALVERSA® for adult patients with locally advanced or metastatic Urothelial Carcinoma (mUC) with susceptible FGFR3 genetic alterations, as determined by an FDA-approved companion diagnostic test, whose disease has progressed on or after at least one line of prior systemic therapy. BALVERSA® is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy. This approval amends the indication previously granted under accelerated approval for patients with mUC with susceptible FGFR3 or FGFR2 alterations after prior platinum-containing chemotherapy. BALVERSA® is a product of Janssen Biotech.
Category: FDA Approvals
KEYTRUDA® (Pembrolizumab)
The FDA on January 12, 2024, approved KEYTRUDA® (Pembrolizumab) with chemoradiotherapy for patients with FIGO 2014 Stage III-IVA Cervical cancer. KEYTRUDA® is a product of Merck.
PADCEV® (Enfortumab vedotin-ejfv)
The FDA on December 15, 2023, approved PADCEV® in combination with Pembrolizumab (KEYTRUDA®) for patients with locally advanced or metastatic Urothelial Cancer. FDA previously granted accelerated approval to this combination for patients with locally advanced or metastatic Urothelial Cancer, who are ineligible for Cisplatin-containing chemotherapy. PADCEV® is a product of Astellas Pharma.
WELIREG® (Belzutifan)
The FDA on December 14, 2023, approved WELIREG® for patients with advanced Renal Cell Carcinoma (RCC) following a Programmed Death receptor-1 (PD-1) or Programmed Death-Ligand 1 (PD-L1) inhibitor and a Vascular Endothelial Growth Factor Tyrosine Kinase Inhibitor (VEGF-TKI). WELIREG® is a product of Merck & Co., Inc.
IWILFIN® (Eflornithine)
The FDA on December 13, 2023, approved IWILFIN® to reduce the risk of relapse in adult and pediatric patients with high-risk Neuroblastoma who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy. IWILFIN® is a product of USWM, LLC.
JAYPIRCA® (Pirtobrutinib)
The FDA on December 1, 2023, granted accelerated approval to JAYPIRCA® for adults with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor. JAYPIRCA® is a product of Eli Lilly and Company.
OGSIVEO® (Nirogacestat)
The FDA on November 27, 2023, approved OGSIVEO® for adult patients with progressing Desmoid tumors who require systemic treatment. This is the first approved treatment for Desmoid tumors. OGSIVEO® is a product of SpringWorks Therapeutics, Inc.
XTANDI® (Enzalutamide)
The FDA on November 16, 2023, approved XTANDI® for non-metastatic Castration-Sensitive Prostate Cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR). XTANDI® is a product of Astellas Pharma US, Inc.
TRUQAP® (Capivasertib)
The FDA on November 16, 2023, approved TRUQAP® with Fulvestrant for adult patients with hormone receptor (HR)-positive, Human Epidermal growth factor Receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations, as detected by an FDA-approved test, following progression on at least one endocrine-based regimen in the metastatic setting, or recurrence on or within 12 months of completing adjuvant therapy. TRUQAP® is a product of AstraZeneca Pharmaceuticals.
KEYTRUDA® (Pembrolizumab)
The FDA on November 16, 2023, approved KEYTRUDA® (Pembrolizumab) 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) adenocarcinoma. KEYTRUDA® is a product of Merck & Co., Inc.