May 2025 Brief

Following clearance from the FDA, a phase 1/2 study will assess OBI-902 in Trop-2-overexpressing solid tumors, with plans for enrollment to begin later this year.

INX-315, a CDK2 inhibitor, gained FDA fast track status in CCNE1-positive platinum-resistant/refractory ovarian cancer.

The FDA requires more data to approve the application of TLX101-CDx for the detection and differentiation of glioma.

Following promising phase 1 data, ISB 2001 has gained fast track designation from the FDA for the treatment of relapsed/refractory multiple myeloma.

The FDA issued an RTF for sBLA of nogapendekin alfa plus BCG for BCG-unresponsive NMIBC papillary disease, following prior positive feedback.

A phase 1b/2 trial in triple-negative breast cancer will assess LP-184 alone and with a PARP inhibitor in advanced cases.

With the clinical hold on the tab-cel application lifted, phase 2 and 3 trials of the T-cell immunotherapy in patients with PTLD may resume.

The resubmitted biologics license application for narsoplimab in transplant-associated thrombotic microangiopathy has been accepted by the FDA.

The FDA granted fast track status to givinostat for treating high-risk polycythemia vera, supporting its potential shown in the ongoing phase 3 GIV-IN PV trial.

Avutometinib given with defactinib is now approved for the treatment of adult patients with recurrent low-grade serous, KRAS-positive ovarian cancer.

ADRX-0706, a Nectin-4-targeted antibody-drug conjugate, has earned FDA fast track designation in advanced cervical cancer.

The FDA cleared the investigational new drug application of IDE849, a potential first-in-class DLL3-targeted antibody-drug conjugate for solid tumors.

THE001, a thermosensitive doxorubicin liposome for soft tissue sarcomas, received FDA orphan drug designation, offering development benefits.

The FDA approved belzutifan as the first oral therapy for advanced or metastatic pheochromocytoma and paraganglioma in patients 12 years and older.

The FDA granted accelerated approval to telisotuzumab vedotin for the treatment of NSCLC with high c-MET protein overexpression.

With significant survival improvements seen, the FDA has granted approval to retifanlimab for the first-line treatment of advanced anal cancer.

BCB-276 has earned regenerative medicine advanced therapy designation from the FDA in diffuse intrinsic pontine glioma, an incurable pediatric tumor.

In an 8 to 1 vote, the Oncologic Drug Advisory Committee determined that findings from the phase 3 STARGLO trial are not applicable to patients in the US with diffuse large B-cell lymphoma.

PT-112 monotherapy advances to phase 3 trial in metastatic castration-resistant prostate cancer after positive FDA end of phase 2 meeting.

In a 6 to 2 vote, the Oncologic Drug Advisory Committee determined that findings from the phase 3 AQUILA trial do support a positive benefit-risk ratio for patients with smoldering multiple myeloma.

The FDA ODAC decided that the overall benefit-risk of the investigational therapy UGN-102 is not favorable in patients with recurrent low-grade, intermediate-risk NMIBC.

The ODAC deemed the results from TALAPRO-2 are not sufficient to conclude a favorable benefit-risk profile for adding talazoparib to enzalutamide in non-HRRm mCRPC.

POLB 001 has been granted FDA orphan drug designation as a preventative therapy for cytokine release syndrome caused by bispecific antibody therapy.

The FDA cleared an investigational new drug application for AVZO-1418/DB-1418, and a phase 1/2 trial in advanced solid tumors will begin later this year.

This priority review designation for sevabertinib in previously treated HER2-mutant non–small cell lung cancer is supported by data from the phase 1/2 SOHO-01 study.

A phase 1b trial plans to evaluate AKY-1189 for the treatment of Nectin-4–expressing tumors.

EBC-129 has been granted FDA fast track designation for the treatment of pancreatic ductal adenocarcinoma, paving the way for development of this antibody-drug conjugate.

The FDA biologics license application for patritumab deruxtecan in EGFR+ NSCLC has been withdrawn following discussions with the agency.