FDA Regulatory Highlights in Oncology: March 2026

The FDA has been active this March, with several landmark approvals and regulatory milestones across hematologic malignancies, solid tumors, and diagnostic imaging.

From a practice-changing approval in frontline Hodgkin lymphoma to new precision tools for prostate and ovarian cancers, these updates reflect the continued shift toward more personalized, biology-driven care.

FDA Issues Tentative Approval to Lu 177 Dotatate Radioequivalent for GEP-NETs

The FDA gave tentative approval to the abbreviated new drug application for PNT2003, a radioequivalent version of lutetium Lu 177 dotatate (Lutathera) indicated for treatment of somatostatin receptor-positive (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut NETs.

FDA OKs New Piflufolastat F 18 Formulation for Prostate Cancer Imaging

The FDA granted approval to a new formulation of piflufolastat F 18 (Pylarify TruVu), a radioactive prostate-specific membrane antigen PET imaging agent, for use in patients with prostate cancer.

The new formulation has been optimized for manufacturing and production efficiency. Specifically, it is expected to increase batch size by approximately 50% while delivering high diagnostic performance consistent with the current formulation on the market. Another key differentiator is the new formulation’s increased radioactivity, which can extend the agent’s shelf life and thereby enable broader patient access.

FDA Grants Priority Review to T-DXd for Post-Neoadjuvant HER2+ Early Breast Cancer

The FDA accepted a supplemental biologics license application (sBLA) and granted priority review to trastuzumab deruxtecan (T-DXd; Enhertu) for the treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease following neoadjuvant HER2-targeted therapy. The Prescription Drug User Fee Act target action date is set for the third quarter of 2026.

The sBLA is supported by results from the DESTINY-Breast05 trial (NCT04622319), a global, randomized, open-label phase 3 study in which T-DXd demonstrated a statistically significant 53% reduction in the risk of invasive disease recurrence or death compared with trastuzumab emtansine (T-DM1; Kadcyla) in patients with high-risk HER2-positive early breast cancer with residual disease after neoadjuvant therapy (HR, 0.47; 95% CI, 0.34-0.66; P <.0001).

Supplemental BLA for Nogapendekin in Bladder Cancer Resubmitted to FDA

The FDA acknowledged receipt of the sBLA for nogapendekin alfa inbakicept-pmln (Anktiva) plus Bacillus Calmette-Guérin (BCG) in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary tumors.

The resubmission follows ongoing discussions with the FDA beginning in January 2026, during which the Agency requested additional data to support its review. The request did not include the initiation or design of any new clinical trials.

FDA Approves MyChoice CDx as Companion Diagnostic for Niraparib for Ovarian Cancer

The FDA approved the MyChoice® CDx test as the companion diagnostic for niraparib (Zejula), a PARP inhibitor. This approval establishes MyChoice CDx as the first and only FDA-approved companion diagnostic in the United States used to identify patients with advanced ovarian cancer who are homologous recombination deficiency positive and thus eligible for treatment with niraparib.

FDA Grants Orphan Drug Designation to Irinotecan Delivery Implant for High-Grade Glioma

The FDA granted orphan drug designation to a locally delivered formulation of irinotecan (ChemoSeed) for the treatment of malignant glioma. The designation covers all high-grade gliomas (WHO grade III and IV tumors), a scope broader than the original application, which had been limited to glioblastoma.

FDA Approves Nivolumab Plus AVD for Classical Hodgkin Lymphoma

The FDA approved the combination of nivolumab (Opdivo) with doxorubicin, vinblastine, and dacarbazine (AVD) for adult and pediatric patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL).

This acceptance followed results from the phase 3 SWOG S1826/CA2098UT (NCT03907488) study. The trial evaluated the safety and efficacy of N-AVD vs brentuximab vedotin (Adcetris) combined with AVD (BV-AVD) in newly diagnosed patients with cHL. Findings from the interim analysis demonstrated that N-AVD had a superior progression-free survival (PFS) vs BV-AVD.

FDA Approves Relacorilant for Platinum-Resistant Ovarian Cancer

The FDA approved relacorilant (Lifyorli) in combination with nab-paclitaxel for the treatment of patients with platinum-resistant ovarian cancer. The NDA submission was based on positive data from the pivotal phase 3 ROSELLA trial (NCT05257408) and earlier phase 2 trials.

The phase 3 ROSELLA trial, evaluating the safety and efficacy of relacorilant plus nab-paclitaxel chemotherapy, successfully met its primary end point of overall survival (OS). The data show a 35% reduction in the risk of death, translating to a 4.1-month improvement in median OS compared with nab-paclitaxel alone. Additionally, data show that there was a 30% reduction in the risk of disease progression, meeting the trial’s dual primary end point of PFS.

FDA Grants Fast Track Status to ALK-Degrading Molecular Glue TRI-611

The FDA granted fast track designation to TRI-611, an investigational, oral molecular glue degrader developed by TRIANA Biomedicines for the treatment of anaplastic lymphoma kinase (ALK)–positive non–small cell lung cancer (NSCLC). The designation is specifically directed toward patients whose disease has progressed following treatment with 2 or more ALK tyrosine kinase inhibitors.

FDA Grants Fast Track Designation to FRα-Targeting ADC for Ovarian Cancer

The FD granted fast track designation to ZW191, an antibody-drug conjugate (ADC) targeting folate receptor-α (FRα), for the treatment of patients with advanced or metastatic platinum-resistant ovarian cancer. ZW191 is engineered to bind to FRα, a cell-surface protein with high expression across several tumor types. FRα is expressed in approximately 75% of high-grade serous ovarian carcinomas.

FDA Grants Lirafugratinib Priority Review in FGFR2-Altered Cholangiocarcinoma

The FDA granted a priority review to a new drug application for lirafugratinib, a highly selective oral FGFR2 inhibitor, for the treatment of patients with cholangiocarcinoma harboring FGFR2 fusions or rearrangements who have received prior therapy. The Prescription Drug User Fee Act target action date is September 27, 2026