Jordyn Sava

New Jersey, United States

Assistant Editor at Targeted Oncology

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Articles

BOND/CORE-001: uGDB as a Biomarker for Viral Therapy in Bladder Cancer

3 days ago | targetedonc.com | Jordyn Sava

Key findings from updated analyses of the BOND-003 and CORE-001 trials (NCT04452591; NCT04387461), presented by Colin P.N. Dinney, MD, PhD, demonstrate the clinical utility of urinary genomic disease burden (uGDB), assessed via the UroAmp platform, in predicting response to cretostimogene grenadenorepvec therapy for bladder cancer.1 The UroAmp assay, a convergent genomic and genetic liquid biopsy, quantifies mutations and DNA alterations in urine tumor DNA to determine minimal residual...
First-Line Disitamab Vedotin/Toripalimab Shows Benefit in HER2+ la/mUC

3 days ago | targetedonc.com | Jordyn Sava

Statistically significant and clinically meaningful progression-free survival (PFS) and overall survival (OS) benefits were seen with disitamab vedotin (RC48) in combination with toripalimab-tpzi (Loqtorzi) vs standard chemotherapy when used as a first-line treatment for patients with HER2-expressing locally advanced or metastatic urothelial carcinoma (la/mUC), meeting the 2 primary end points of the phase 3 RC48-C016 trial (NCT05302284).1 Compared with the strongly positive findings of a...
Durvalumab Plus BCG Improves Survival in Early Bladder Cancer

6 days ago | targetedonc.com | Jordyn Sava

Treatment with the combination of durvalumab (Imfinzi) and standard-of-care Bacillus Calmette-Guérin (BCG) induction and maintenance therapy led to a statistically significant and clinically meaningful improvement in disease-free survival (DFS) when used for the treatment of patients with high-risk non-muscle invasive bladder cancer (NMIBC) vs BCG induction and maintenance therapy alone, according to high-level data from the phase 3 POTOMAC trial (NCT03528694).1 While the study was not...
FDA Fast-Tracks Givinostat for Polycythemia Vera Treatment

1 week ago | targetedonc.com | Jordyn Sava

The FDA has granted givinostat (Duvyzat) fast track status for the treatment of patients with polycythemia vera (PV). Givinostat is an orally administered histone deacetylase (HDAC) inhibitor. The agent is currently being assessed in the ongoing phase 3 GIV-IN PV trial (NCT06093672) in patients with JAK2 V617F-positive, high-risk PV.
FDA Issues Refusal to File for Nogapendekin Alfa Plus BCG in Papillary NMIBC

1 week ago | targetedonc.com | Jordyn Sava

The FDA has issued a refusal to file (RTF) letter for the supplemental biologics license application (sBLA) seeking approval of nogapendekin alfa inbakicept (Anktiva) in combination with Bacillus Calmette-Guérin (BCG). This indication is for patients with BCG-unresponsive non–muscle invasive bladder cancer (NMIBC) with papillary disease without carcinoma in situ (CIS). A Type A meeting has been requested to address discrepancies between prior FDA guidance and the RTF.
FDA Grants ISB 2001 Fast Track Designation in RRMM

1 week ago | targetedonc.com | Jordyn Sava

The FDA granted ISB 2001 fast track designation for the potential treatment of adult patients with relapsed/refractory multiple myeloma (RRMM). This indication is for patients with RRMM who have received at least 3 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. The investigational trispecific antibody therapeutic is currently undergoing evaluation in a phase 1 dose-expansion study.
RP1 and the Future of Oncolytic Therapy in Melanoma

1 week ago | targetedonc.com | Jordyn Sava

RP1 (vusolimogene oderparepvec) is a genetically engineered next-generation herpes simplex virus that is intended to lyse tumor cells, induce systemic anti-tumor immune response with enhanced T-cell activation, augment immunogenic cell death via the addition of the fusogenic GALV payload, while enhancing replication in tumor cells and not healthy cells.
First-Line Adagrasib Active in STK11/KRAS G12C-Mutated NSCLC

1 week ago | oncnursingnews.com | Jordyn Sava

In a phase 2 cohort of the KRYSTAL-1 trial (NCT03785249), first-line adagrasib (Krazati) produced a clinically meaningful objective response rate (ORR) of 30.3% (95% CI, 15.6%–48.7%) and a disease control rate of 66.7% in patients with advanced non–small cell lung cancer (NSCLC) harboring both KRAS G12C and STK11 mutations, according to data presented at the 2025 AACR Annual Meeting.1 The ORR appeared numerically higher in patients without KEAP1 comutations (38%) compared with those with...
FDA Actions in Oncology: April 2025 Approvals and Designations

1 week ago | targetedonc.com | Jordyn Sava

April 2025 saw significant activity in FDA oncology news, with several notable approvals. The FDA approved the combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) as a first-line treatment for adult and pediatric patients (≥12 years) with microsatellite instability-high or mismatch repair deficient (dMMR) metastatic colorectal cancer.
FDA Fast Tracks INX315 in Ovarian Cancer

2 weeks ago | targetedonc.com | Jordyn Sava

The FDA granted fast track status to INX-315 for the potential treatment of CCNE1-amplified, platinum-resistant/refractory ovarian cancer. INX-315 is a novel CDK2 inhibitor targeting a resistance mechanism to other therapies. INX-315 is being evaluated in a phase 1/2 trial, including an ovarian cancer expansion cohort.