The Targeted Pulse: FDA Oncology Roundup

It has been a significant week for the oncology community, with the FDA issuing several key decisions spanning diagnostic imaging, novel antibody-drug conjugates (ADCs), and bispecific therapies. From breakthroughs in rare cancers like NRG1-positive cholangiocarcinoma to the resumption of suspended clinical trials, here is your weekly roundup of FDA news in oncology.

1. Priority Review Granted to Ifinatamab Deruxtecan (I-DXd) for Advanced SCLC

The FDA has granted priority review to the biologics license application (BLA) for ifinatamab deruxtecan (I-DXd). This ADC is being developed for patients with pretreated extensive-stage small cell lung cancer (ES-SCLC).

The application is supported by data from the phase 2 IDEATE-Lung01 (NCT05280470), which demonstrated promising objective response rates in a patient population that historically has very limited options after progressing on frontline chemo-immunotherapy. The priority review designation shortens the FDA’s goal for taking action to 6 months, with a target action date of October 10, 2026.

2. Zenocutuzumab sBLA Filed for NRG1-Positive Cholangiocarcinoma

A supplemental BLA for zenocutuzumab (MCLA-128) has been submitted to the FDA for the treatment of patients with advanced NRG1-positive cholangiocarcinoma.

Zenocutuzumab is a first-in-class bispecific antibody designed to bind to HER2 and HER3, effectively blocking the NRG1-HER3 interaction that drives tumor growth in these specific patients. This filing follows a trend of "agnostic-like" developments for NRG1 fusions, which are rare but highly actionable drivers across several solid tumors, including biliary tract cancers.

3. FDA Accepts NDA for 18F-FET PET Imaging in Glioma

In a major step forward for neuro-oncology diagnostics, the FDA has accepted the new drug application (NDA) for ¹⁸F-FET (¹⁸F-fluroethyl-L-tyrosine [Pixclara; TLX101-Px]).

If approved, this PET imaging agent will be used for the evaluation of patients with suspected or confirmed gliomas. Unlike standard MRI, which can sometimes struggle to differentiate between tumor progression and pseudoprogression,¹⁸F-FET PET provides metabolic data that can more accurately map tumor borders and monitor therapy response in brain cancer patients.

4. Fast Track Designation for OPN-6602 in Multiple Myeloma

The FDA has granted fast track designation to OPN-6602, an investigational immunotherapy for the treatment of relapsed or refractory multiple myeloma.

OPN-6602 is designed to target specific antigens on myeloma cells to trigger a potent immune response. The fast track program is intended to facilitate the development and expedite the review of drugs that treat serious conditions and fill unmet medical needs, allowing for more frequent communication with the FDA and eligibility for rolling review.

5. Clinical Hold Lifted on Lorigerlimab Ovarian Cancer Trial

The FDA has lifted the clinical hold on the phase 2 trial of lorigerlimab, a bispecific DART molecule being studied in patients with ovarian cancer and other advanced solid tumors.

The trial was previously paused to address specific safety or manufacturing queries. With the hold removed, investigators can resume enrollment and dosing, continuing the evaluation of how this dual-targeting agent (which targets PD-1 and CTLA-4) may improve outcomes for patients who have exhausted standard-of-care systemic therapies.

6. Orphan Drug Designation for Eftilagimod Alfa in Soft Tissue Sarcoma

Eftilagimod alfa, a soluble LAG-3 protein and MHC class II agonist, has received orphan drug designation (ODD) for the treatment of soft tissue sarcoma.

ODD is granted to drugs intended for the treatment of rare diseases affecting fewer than 200,000 people in the United States. This designation provides Immutep, the developer, with various incentives, including tax credits for clinical trials, waived FDA fees, and seven years of market exclusivity upon approval. Eftilagimod alfa is currently being studied in combination with other therapies to prime the immune system to better recognize and attack sarcoma cells.

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