News|Articles|August 1, 2025
July's Oncology Approvals: A Landmark Month for Cancer Treatment Advancements
Author(s)Targeted Oncology Staff
Fact checked by: Sabrina Serani
July marks a transformative month in oncology with the FDA's groundbreaking approvals and updates, enhancing treatment options for various cancers.
July has proven to be a pivotal month for oncology, with the US FDA delivering a series of significant approvals and updates that promise to reshape treatment landscapes across various cancer types. From novel therapies for hard-to-treat hematologic malignancies to expanded indications for established drugs and innovative diagnostic tools, the advancements this month offer renewed hope and expanded options for patients and clinicians alike. Dive into our comprehensive roundup of all the crucial FDA oncology news from July.
Drug Approvals
On July 2, the FDA granted accelerated approval to linvoseltamab (Lynozyfic, formerly REGN5458) for treating relapsed/refractory multiple myeloma in patients who have progressed after 4 or more prior lines of therapy.
Also on July 2, the FDA granted accelerated approval to sunvozertinib (Zegfrovy) for adult patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations whose disease has progressed after platinum-based chemotherapy.
Accompanying the approval of sunvozertinib was the approval of the Oncomine™ Dx Express Test on the Ion Torrent™ Genexus™ Dx Integrated Sequencer as a companion diagnostic.
On July 7, the FDA granted approval to SIR-Spheres Y-90 resin microspheres in unresectable hepatocellular carcinoma (HCC). SIR-Spheres was previously approved by the FDA for the treatment of patients with colorectal cancer that has metastasized to the liver.
On July 7, Celltrion USA announced the US commercial launch of denosumab-bmwo (Stoboclo) and denosumab-bmwo (Osenvelt), biosimilars indicated for cancer-related skeletal events.
On July 24, Zydus Lifesciences Limited received tentative approval from the FDA for its generic versions of ibrutinib (Imbruvica) tablets in 140 mg, 280 mg, and 420 mg strengths.
Complete Response Letters
On July 21, the FDA issued a complete response letter regarding the supplemental biologics license application for glofitamab (Columvi) in combination with gemcitabine and oxaliplatin, indicating that data from the phase 3 STARGLO study (NCT04408638) did not provide sufficient evidence to support the proposed second-line DLBCL indication within the US patient population.
On July 22, Replimune Group Inc announced that it received a complete response letter from the FDA regarding its biologics license application for RP1 (vusolimogene oderparepvec), an oncolytic immunotherapy, in combination with nivolumab (Opdivo) for the treatment of advanced melanoma, indicating that the FDA was unable to approve the application in its current form, primarily citing concerns that the pivotal IGNYTE trial (NCT03767348) was not considered an adequate and well-controlled clinical investigation to provide substantial evidence of effectiveness.
Fast Track, Orphan Drug, and Breakthrough Therapy Designations
At the beginning of the month, the FDA granted breakthrough device designation to the TOBY Test for bladder cancer, a urine-based test using AI algorithms for more accessible bladder cancer detection and monitoring.
The SonoClear System, a novel acoustic coupling fluid, received FDA breakthrough device designation for significantly improving intraoperative ultrasound imaging during neurosurgical procedures, especially for aggressive neurological tumors like gliomas.
On July 7, the FDA granted orphan drug designation to FF-10832 (liposomal gemcitabine) in biliary tract cancer highlighting the significant unmet medical need for this aggressive and rare malignancy.
Also on July 7, the FDA granted orphan drug designation to IL13Ra2-targeted CAR T-cells known as MB-101 for recurrent diffuse and anaplastic astrocytoma and glioblastoma. Early clinical data, including complete responses in patients with "hot" tumors treated with IL13Ra2-targeted CAR T cells alone, support the potential of this immunotherapeutic approach.
The FDA granted orphan drug designation to ADRX-0405, an investigational antibody-drug conjugate (ADC) being developed by Adcentrx Therapeutics, for the treatment of gastric cancer.
On July 15, the FDA granted SH-110, a novel oral suspension, orphan drug designation for the treatment of patients with glioma.
On July 14, ZEN-3694 received fast track designation for the treatment of metastatic or unresectable NUT carcinoma. This is a significant development for an aggressive and deadly cancer with no currently approved treatments.
On July 17, the FDA granted breakthrough therapy designation to the combination of fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) and pertuzumab (Perjeta) for the first-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer.
On July 18, the FDA granted orphan drug designation to ICT01, a humanized anti-BTN3A monoclonal antibody. This designation underscores the critical unmet need in acute myeloid leukemia (AML), particularly for older or unfit patients for whom intensive chemotherapy is not an option.
On July 22, the FDA granted fast track designation to a novel HER3-targeting ADC, DB-1310, for the treatment of adult patients with advanced, unresectable or metastatic nonsquamous NSCLC.
On July 25, Verastem Oncology announced that the FDA has granted fast track designation to VS-7375, an investigational oral KRAS G12D (ON/OFF) inhibitor, for patients with KRAS G12D-mutated locally advanced or metastatic adenocarcinoma of the pancreas as a first-line treatment and for patients who have progressed after at least 1 prior line of standard systemic therapy.
On July 29, MAIA Biotechnology’s investigational telomere-targeting agent, ateganosine (THIO, 6-thio-2’-deoxyguanosine, or 6-thio-dG), was granted fast track designation by the US FDA for the treatment of advanced NSCLC that has progressed after immune checkpoint inhibitor therapy.
Also on July 29, the investigational allogeneic adipose stem cell-loaded oncolytic virus, CLD-201 (SuperNova), was granted fast track designation by the US FDA for the treatment of soft tissue sarcoma.
Priority Review
On July 17, the FDA granted priority review to the new drug application for TAR-200 in Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non–muscle-invasive bladder cancer (HR-NMIBC) with carcinoma in situ with or without papillary tumors.
On July 25, the FDA accepted the biologics license application of tabelecleucel (tab-cel; Ebvallo) for priority review in adult and pediatric patients aged 2 years and older with relapsed or refractory EBV+ posttransplant lymphoproliferative disease (PTLD) who have received at least 1 prior therapy.
On July 28, the FDA granted priority review and breakthrough therapy designation to durvalumab (Imfinzi), underscoring the potential for durvalumab to become the first and only perioperative immunotherapy-based regimen in early-stage gastric/gastroesophageal junction cancer.
More FDA News
On July 2, the FDA issued comprehensive draft guidance for the development of novel drugs and biologics targeting myelodysplastic syndromes (MDS). This document outlines the agency's current thinking on clinical trial design, patient selection, safety reporting, and efficacy end points for these complex hematologic disorders.
On July 9, the FDA accepted the supplemental new drug application for decitabine and cedazuridine (Inqovi) plus venetoclax (Venclexta) in newly diagnosed patients with AML ineligible for intensive chemotherapy.
On July 14, 2025, a new drug application for relacorilant was submitted to the FDA based on phase 3 ROSELLA (NCT05257408) data.
On July 15, Pierre Fabre Laboratories assumed global responsibility for clinical development and manufacturing of tab-cel, and Atara Biotherapeutics resubmitted the biologics license application for tab-cel following FDA feedback, with potential US approval pending.
On July 16, the FDA cleared an investigational new drug application for GL-IL2-138, a small-molecule modulator of natural IL-2.
On July 17, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted that the benefit-risk profile of belantamab mafodotin (Blenrep)-based combinations was unfavorable for the treatment of early relapsed/refractory multiple myeloma.
On July 28, the FDA cleared investigational new drug applications for the novel agents ZW251, an ADC, and betabart (RV-01), a radiopharmaceutical. The regulatory clearances authorize the initiation of first-in-human phase 1 trials of these investigational treatments in patients with solid tumors.
On July 29, AbbVie submitted a supplemental new drug application to the US FDA for a fixed-duration, all-oral combination regimen of venetoclax (Venclexta) and acalabrutinib (Calquence) for patients with previously untreated chronic lymphocytic leukemia (CLL).
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