Tools: Vol 40, No. 5

Approved Drugs

• On June 18, 2025, the FDA approved Monjuvi^® (tafasitamab-cxix) (Incyte Corporation) with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma.
• On June 23, the FDA granted accelerated approval to Datroway^® (datopotamab deruxtecan-dlnk) (Daiichi Sankyo) for adults with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.
• On July 2, the FDA granted accelerated approval to Lynozyfic^® (linvoseltamab-gcpt) (Regeneron Pharmaceuticals), a bispecific B-cell maturation antigen-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
• On July 2, the FDA granted accelerated approval to Zegfrovy^® (sunvozertinib) (Dizal (Jiangsu) Pharmaceutical) for adult patients with locally advanced or metastatic NSLC EGFR-exon 20 insertion mutations, as detected by an FDA approved test, whose disease has progressed on or after platinum-based chemotherapy.
• On August 6, the FDA granted accelerated approval to Modeyso^® (dordaviprone) (Jazz Pharmaceuticals), a protease activator, for adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.
• On August 8, the FDA granted accelerated approval to Hernexeos^® (zongertinib) (Boehringer Ingelheim Pharmaceuticals), a kinase inhibitor, for adults with unresectable or metastatic NSCLC cancer whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy.

Drugs in the News

• The FDA granted orphan drug designation to ADRX-0405 (Adcentrx Therapeutics) for the treatment of patients with gastric cancer.
• The FDA granted fast track designation to ateganosine (MAIA Biotechnology) for the treatment of NSCLC.
• The FDA granted fast track designation to its birelentinib (DZD8586) (Dizal) for the treatment of adult patients with relapsed/ refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least 2 prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.
• The FDA granted priority review to the supplemental biologics license application for Breyanzi® (lisocabtagene maraleucel) (Bristol Meyers Squibb) as a potential treatment for adult patients with relapsed or refractory marginal zone lymphoma who have received at least 2 prior lines of systemic therapy.
• The FDA granted fast track designation to CLD-201 (Calidi Biotherapeutics), an allogeneic adipose stem-cell loaded oncolytic virus, for the treatment of soft tissue sarcoma.
• The FDA granted breakthrough therapy designation to daraxonrasib (Revolution Medicines), a RAS(ON) multi-selective inhibitor, for previously treated metastatic pancreatic ductal adenocarcinoma in patients with KRAS G12 mutations.
• The FDA granted fast track designation to DB-1310 (DualityBio), a HER3-targeting antibody-drug conjugate, for the treatment of adult patients with advanced, unresectable or metastatic nonsquamous non-small cell lung cancer with an EGFR exon 19 deletion or L858R mutation with disease progression on or after treatment with a third-generation EGFR tyrosine kinase inhibitor and platinum-based chemotherapy.
• The FDA granted regenerative medicine advanced therapy designation to detalimogene voraplasmid (enGene Holdings), an investigational therapy for the treatment of high-risk, Bacillus Calmette-Guérin-unresponsive, non-muscle invasive bladder cancer with carcinoma in situ.
• The FDA granted breakthrough therapy designation to elironrasib (Revolution Medicines), a RAS(ON) G12C-selective inhibitor, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who have received prior chemotherapy and immunotherapy but have not been previously treated with a KRAS G12C inhibitor.
• The FDA granted breakthrough therapy designation to Enhertu^® (Daiichi Sankyo, AstraZeneca) in combination with pertuzumab for the first-line treatment of adult patients with unresectable or metastatic HER2 positive breast cancer.
• The FDA granted orphan drug designation to FF-10832 (Fujifilm), an investigational liposomal formulation of gemcitabine, for the treatment of biliary tract cancer.
• The FDA granted orphan drug designation to GLIX1 (Hemispherian) for the treatment of malignant glioma.
• The FDA granted regenerative medicine advanced therapy designation to GLPG5101 (Galapagos), a second generation antiCD19/4-1BB CAR-T product candidate, for the treatment of relapsed/refractory mantle cell lymphoma.
• The FDA granted orphan drug designation to ICT01 (ImCheck Therapeutics), a humanized anti-butyrophilin 3A monoclonal antibody designed to selectively activate γ9δ2 T cells, for the treatment of acute myeloid leukemia.
• The FDA granted priority review to the supplemental Biologics License Application for Imfinzi^® (durvalumab) (AstraZeneca) for the treatment of patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction cancers.
• The FDA granted orphan drug designation to Mustang for MB-101 (Mustang Bio), IL13Ra2- targeted CAR T-cells, for the treatment of recurrent diffuse and anaplastic astrocytoma and glioblastoma.
• The FDA granted orphan drug designation to quemliclustat (Arcus Biosciences), an investigational small molecule CD73 inhibitor, for the treatment of pancreatic cancer.
• The FDA granted priority review for Syndax Pharmaceuticals’ supplemental new drug application for Revuforj^® (revumenib) for the treatment of relapsed or refractory mutant NPM1 acute myeloid leukemia.
• The FDA granted orphan drug designation to SH-110 (Shorla Oncology), a palatable oral suspension, to treat Glioma by providing a liquid form of treatment for patients who have difficulty swallowing.
• The FDA granted fast track designation to SGR-1505 (Schrödinger), a clinical stage MALT1 inhibitor, for the treatment of adult patients with Waldenström macroglobulinemia that have failed at least 2 lines of therapy, including a Bruton’s tyrosine kinase inhibitor.
• The FDA granted priority review to TAR-200 (Johnson & Johnson), an intravesical gemcitabine releasing system, for the treatment of patients with Bacillus CalmetteGuérin-unresponsive high-risk non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors.
• The FDA granted Fast Track designation to TRE-515 (Trethera) for the treatment of prostate cancer.
• The FDA granted fast track designation to VS-7375 (Verastem Oncology), an oral KRAS G12D inhibitor, for the first-line treatment of patients with KRAS G12D-mutated locally advanced or metastatic adenocarcinoma of the pancreas (PDAC) and for the treatment of patients with KRAS G12D-mutated locally advanced or metastatic PDAC who have received at least 1 prior line of standard systemic therapy.
• The FDA granted fast track designation to ZEN-3694 (Zenith Epigenetics) in combination with abemaciclib for the treatment of metastatic or unresectable NUT carcinoma in patients who have received at least 1 line of prior chemotherapy.

Devices and Assays

• The FDA granted breakthrough device designation to ArteraAI Prostate (Artera), an AI precision medicine tool intended to assist clinicians with risk-based decisions for patients with localized prostate cancer.
• The FDA granted breakthrough device designation to Castle Biosciences’ DecisionDxMelanoma test, a gene expression profile test that provides comprehensive, personalized results to guide risk-aligned management decisions for patients diagnosed with stage I-III cutaneous melanoma.
• The FDA granted 510(k) clearance to Marie^® (Leo Cancer Care), an upright radiotherapy platform.
• The FDA has approved the Oncomine™ Dx Express Test (Thermo Fisher) on the Ion Torrent™ Genexus™ Dx Integrated Sequencer as an in vitro diagnostic assay for use as a companion diagnostic for Zegfrovy in EGFR exon 20 insertion mutation–positive non–small cell lung cancer and for use in tumor profiling.
• The FDA has approved SIR-Spheres Y-90 resin microspheres (Sirtex) for the treatment of patients with unresectable hepatocellular carcinoma.
• The FDA granted breakthrough device designation to the SonoClear^® system (SonoClear) for use in intracranial ultrasound procedures.
• The FDA granted breakthrough device designation to TOBY’s AI-powered urine test for early bladder cancer detection.