Tony Berberabe, MPH

The T-cell immunotherapy Orca-T has gained FDA approval in acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) and myelodysplastic syndromes (MDS).

Interim data from the LEGEND pivotal cohort show detalimogene achieved complete responses in more than half of patients with BCG-unresponsive non-muscle invasive bladder cancer.

S-HIFU achieved 71% ADT-free survival at 30 months in recurrent prostate cancer post-radiation, with better outcomes in patients with lower PSA and Gleason scores.

The monoclonal antibody LYT-200 demonstrated promising clinical activity and a favorable safety profile in patients with high-risk myelodysplastic syndrome.

The phase 3 LITESPARK-012 trial failed to meet primary end points of PFS/OS for adding belzutifan or quavonlimab to the standard pembro/lenvatinib doublet.

Phase 1 trial of JANX014, a PSMA-targeted T-cell engager, begins in mCRPC, building on prior safety data to expand treatment strategies.

The FDA has granted a priority review to the supplemental biologics license application for enfortumab vedotin/pembrolizumab to all patients with MIBC regardless of cisplatin eligibility.

Naomi Haas, MD, shares her insights on the rapidly shifting landscape of adjuvant and neoadjuvant therapies in renal cell carcinoma.

The first patient has been dosed in a phase 1 trial (NCT05997615) of VIR-5500, a dual-masked PSMA-targeting T-cell engager for metastatic prostate cancer.

The FDA has granted fast track and rolling review status to Celltrion’s CT-P71, a Nectin-4 targeting ADC for treating advanced urothelial carcinoma.

The FDA has agreed on the design of two phase 3 trials of the antibody-drug conjugate CRB-701 in HNSCC and cervical cancer.

Learn the warning signs of renal medullary carcinoma—sickle cell trait, right-sided mass—and why INI1 testing changes therapy and survival.

Proton therapy showed an advantage in early toxicity mitigation vs radiotherapy in patients with oropharyngeal squamous cell carcinoma.

CMS has issued a permanent billing and reimbursement J-code, J9183, for the gemcitabine intravesical system (Inlexzo) in NMIBC.

The FDA has extended the deadline to review Orca-T for the treatment of myelodsyplastic syndromes and acute leukemias with a PDUFA date of July 6, 2026.

Transdermal estradiol offers fewer hot flashes and lower fracture rates, but higher rates of gynecomastia, as it meets the noninferiority bar against LHRH agonists.

Use of the ProSense Cryoablation System in patients with kidney cancer resulted in an 83.9% recurrence-free rate among 112 patients in the ICESECRET clinical trial (NCT02399124).

The FDA approved a label change for nadofaragene firadenovec-vncg (Adstiladrin) in non–muscle-invasive bladder cancer to improve preparation time.

The combination of selinexor and ruxolitinib achieved a statistically significant and sustained reduction in spleen volume compared with ruxolitinib alone in patients with JAK inhibitor treatment-naïve myelofibrosis, though symptom improvement was comparable across both arms.

Positive efficacy signals in progression-free survival (PFS) and objective response rate (ORR) did not translate into an overall survival (OS) benefit for first-line lenvatinib (Lenvima) plus pembrolizumab (Keytruda) in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

Nadofaragene firadenovec-vncg (Adstiladrin) received an expanded NCCN recommendation for patients with BCG-unresponsive NMIBC.

Early results from TALAPRO-3 suggest that the combination of talazoparib and enzalutamide may redefine the treatment paradigm for HRR gene-mutated mCSPC, demonstrating that targeting DNA damage repair earlier in the disease course substantially delays radiographic progression.

The combination of nogapendekin alfa inbakicept-pmln (Anktiva) and Bacillus Calmette-Guérin was added to the NCCN clinical guidelines for bladder cancer, according to the manufacturer.

Three-year follow-up data from the phase 3 RATIONALE-309 trial show that tislelizumab plus chemotherapy provides durable progression-free survival and a clinically meaningful overall survival advantage over placebo in recurrent or metastatic nasopharyngeal carcinoma.

Sacituzumab govitecan plus pembrolizumab may enable bladder preservation in MIBC.

A phase 3 trial evaluating TLX591-Tx (lutetium-177 (177Lu) rosopatamab tetraxetan) showed positive safety and toxicity profile in prostate cancer.

A supplemental Biologics License Application has been submitted for nogapendekin alfa inbakicept-pmln (Anktiva) plus BCG for patients with BCG-unresponsive non-muscle invasive bladder cancer with papillary tumors.

PIM-1 kinase inhibitors in myelofibrosis offer new targets to overcome relapsed and refractory disease.

The FDA has granted a priority review and accepted the NDA for rusfertide in PV.

Clinical validation results show changes in methylated circulating tumor DNA (ctDNA) measured prior to treatment initiation and before cycle 3 of therapy were strongly associated with objective response and clinical benefit.