Tools (June 2025)

Approved Drugs

• On March 4, 2025, the US Food and Drug Administration (FDA) approved Tevimbra® (tislelizumab-jsgr) (Beigene) 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.
• On March 19, the FDA granted traditional approval to Keytruda® (pembrolizumab) (Merck) with trastuzumab, fluoropyrimidineand 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.
• On March 26, the FDA approved Cabometyx® (cabozantinib) (Exelixis) 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.
• On March 28, the FDA approved neoadjuvant Imfinzi® (durvalumab) (AstraZeneca) plus gemcitabine and cisplatin, followed by single-agent adjuvant durvalumab after radical cystectomy, for adults with muscle-invasive bladder cancer.
• On April 8, the FDA approved Opdivo® (nivolumab) with Yervoy® (ipilimumab) (Bristol Myers Squibb) for adult and pediatric patients 12 years of age and older with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.
• On April 10, the FDA approved Vitrakvi® (larotrectinib) (Bayer), 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.
• On April 11, the FDA approved Opdivo (nivolumab) with Yervoy (ipilimumab) (Bristol Myers Squibb) for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC).
• On April 23, the FDA approved penpulimabkcqx (Akeso, Inc.) with cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic nonkeratinizing nasopharyngeal carcinoma (NPC) and as a single agent for adults with metastatic non-keratinizing NPC.

Drugs in the News

• The FDA granted rare pediatric disease designation to perillyl alcohol (NEO100) (Neonc Technologies) for diffuse high-grade gliomas in children and adolescents.
• The FDA granted breakthrough therapy designation to darovasertib (Ideaya Biosciences) for the neoadjuvant treatment of adult patients with primary uveal melanoma where enucleation has been recommended.
• The FDA granted fast track designation to azercabtagene zapreleucel (azer-cel) (Imugene Limited), an allogeneic CAR T-cell therapy, for the treatment of relapsed or refractory diffuse large B-cell lymphoma.
• The FDA granted orphan drug designation to HLX22 (Henlius), an anti-HER2 monoclonal antibody, for the treatment of gastric cancer.
• The FDA granted orphan drug designation to nesuparib (Onconic Therapeutics) for the treatment of gastric cancer, including gastroesophageal junction cancer.
• The FDA granted orphan drug designation for its bifunctional therapeutic peptide, PEP-010 (PEP-Therapy) for the treatment of pancreatic cancer.
• The FDA granted orphan drug designation to the BTK degrader bexobrutideg (Nurix) for the treatment of Waldenström macroglobulinemia.
• The FDA granted orphan drug designation to rhenium (186Re) obisbemeda (Plus Therapeutics), a novel injectable radiotherapy, for the treatment of leptomeningeal metastases in patients with lung cancer.
• The FDA granted orphan drug designation to bexmarilimab (Faron), an investigational immunotherapy, for the treatment of patients with myelodysplastic syndromes.
• The FDA granted fast track designation to RZ-001 (Rznomics) for the treatment of HCC.
• The FDA granted fast track designation to PYX-201 (Pyxis Oncology), an antibody drug conjugate, for the treatment of adult patients with recurrent or metastatic head and neck squamous cell carcinoma whose disease has progressed after treatment with platinum-based chemotherapy and an anti-PD-(L)1 antibody.
• The FDA granted fast track designation to rhenium (186Re) obisbemeda (Plus Therapeutics) for the treatment of leptomeningeal metastases in patients with lung cancer.
• The FDA accepted and granted priority review to a supplemental biologics license application seeking the approval of Keytruda (pembrolizumab) (Merck) as neoadjuvant treatment, then continued as adjuvant therapy in combination with standard-of-care radiotherapy with or without cisplatin, and then as monotherapy as maintenance for patients with resectable, locally advanced head and neck squamous cell carcinoma.

Devices and Assays

• The FDA granted breakthrough device designation to Paige PanCancer Detect (Paige) an AI-assisted diagnostic application intended to assist pathologists in the detection of foci that are suspicious for cancer from multiple tissues and organs.
• The FDA granted breakthrough device designation to Damo Panda (Alibaba), an artificial intelligence-powered tool developed for early pancreatic cancer detection.
• The FDA clears new Clarius Prostate AI (Clarius Mobile Health), a semi-automatic tool that quickly and accurately calculates prostate volume during an ultrasound exam helping physicians assess and diagnose common urologic conditions in minutes.