Industry News

FDA Approves Penpulimab-kcqx for Non-Keratinizing Nasopharyngeal Carcinoma

On April 23, the US Food and Drug Administration FDA approved penpulimab-kcqx with cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma and as a single agent for adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.
For more information, read the FDA announcement.
Posted on 4/24/2025

FDA Approves Nivolumab With Ipilimumab for Unresectable or Metastatic Hepatocellular Carcinoma

On April 11, the US Food and Drug Administration (FDA) approved nivolumab with ipilimumab for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma.
For more information, read the FDA announcement or the Bristol Myers Squibb press release.
Posted on 04/11/2025

FDA Approves Larotrectinib for Adult and Pediatric Patients With NTRK Gene Fusion-Positive Solid Tumors

On April 10, the US Food and Drug Administration (FDA) approved larotrectinib, a first-in-class TRK inhibitor for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity.
For more information, read the Bayer press release.
Posted on 4/11/2025

FDA Expands Pluvicto’s Metastatic Castration-Resistant Prostate Cancer Indication

On March 28, the US Food and Drug Administration (FDA) expanded the indication for lutetium Lu 177 vipivotide tetraxetan to include adults with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathway inhibitor therapy and are considered appropriate to delay taxane-based chemotherapy.
For more information, read the FDA announcement or the Novartis press release.
Posted on 4/8/25

FDA Approves Nivolumab With Ipilimumab for Unresectable or Metastatic MSI-H or dMMR Colorectal Cancer

On April 8, the US Food and Drug Administration (FDA) approved nivolumab with ipilimumab for adult and pediatric patients 12 years of age and older with unresectable or metastatic microsatellite instability-high or mismatch repair-deficient colorectal cancer.
For more information, read the FDA announcement.
Posted on 4/08/25

FDA Approves Durvalumab for Muscle-Invasive Bladder Cancer

On March 28, the US Food and Drug Administration (FDA) approved durvalumab with gemcitabine and cisplatin as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment following radical cystectomy, for adults with muscle-invasive bladder cancer.
For more information, read the FDA announcement.
Posted on 3/28/2025

FDA Approves Cabozantinib for Pancreatic and Extra-Pancreatic Neuroendocrine Tumors

On March 26, the US Food and Drug Administration (FDA) approved cabozantinib for the treatment of adult and pediatric patients aged 12 years or older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors and well-differentiated extra-pancreatic neuroendocrine tumors.
For more information, read the FDA announcement or the Exelixis press release.
Posted on 3/26/25

FDA Approves Pembrolizumab for HER2 Positive Gastric or Gastroesophageal Junction Adenocarcinoma Expressing PD-L1

On March 19, the US Food and Drug Administration (FDA) granted traditional approval to pembrolizumab with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1.
For more information read the FDA announcement.
Posted on 3/19/25

Geron Announces European Commission Approval of Imetelstat for the Treatment of Adults With Transfusion-Dependent Anemia

On March 11, the European Commission granted marketing authorization for imetelstat as a monotherapy for the treatment of adult patients with transfusion-dependent anemia due to very low, low, or intermediate-risk myelodysplastic syndromes without an isolated deletion 5q cytogenetic abnormality who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy.
For more information, read the Geron press release.
Posted on 3/13/25

FDA Approves Tislelizumab-jsgr for First-line Treatment of Advanced Esophageal Squamous Cell Carcinoma in Combination With Chemotherapy

On March 4, the US Food and Drug Administration (FDA) approved tislelizumab-jsgr in combination with platinum-containing chemotherapy for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1.
For more information, read the Beigene press release.
Posted on 3/12/25