Sabrina Serani

New York

Senior Editor at Targeted Oncology

Senior Editor at MJH Life Sciences

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Articles

FDA Clears IND for Novel DLL3-Targeted ADC in Solid Tumors

1 week ago | targetedonc.com | Sabrina Serani

The FDA has cleared the investigational new drug (IND) application for IDE849 (SHR-4849) in solid tumor treatment. IDE849 is a first-in-class delta-like ligand 3 (DLL3) topoisomerase-I (TOP1) antibody-drug conjugate (ADC). With this clearance, a phase 1 study (NCT06443489) will begin. The IND for the first-in-class ADC IDE849 has been cleared by the FDA, paving the way for a phase 1 study to investigate the agent in solid tumors.
NCCN Adds Naxitamab to Practice Guidelines for High-Risk Neuroblastoma

1 week ago | targetedonc.com | Sabrina Serani

Naxitamab-gqgk (Danyelza) has been added to the National Comprehensive Cancer Network’s (NCCN) Clinical Practice Guidelines in Oncology as a Category 2A treatment for high-risk neuroblastoma.1“We are very pleased with NCCN’s update of the NCCN Guidelines to include naxitamab-gqgk.
T-DXd Shows Benefits in Phase 3 Early Breast Cancer Study

1 week ago | targetedonc.com | Sabrina Serani

Fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) followed by paclitaxel, trastuzumab (Herceptin), and pertuzumab (Perjeta; THP) led to a statistically significant and clinically meaningful improvement in pathologic complete response (pCR) vs the standard of care when used in the neoadjuvant setting for patients with high-risk, locally advanced, HER2-positive, early-stage breast cancer, according to high-level results from the phase 3 DESTINY-Breast11 study (NCT05113251).1 This marks the first...
FDA Lifts Clinical Hold on Tab-Cel Application in EBV+ PTLD

1 week ago | targetedonc.com | Sabrina Serani

The FDA has lifted the clinical hold on the investigational new drug (IND) application of tablecleucel (tab-cel; Ebvallo) for the treatment of Epstein-Barr Virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD)The IND was placed on clinical hold in January 2025 following a complete response letter (CRL) due to good manufacturing practices (GMP) compliance issues. Atara Biotherapeutics, the manufacturer, has provided supplemental data supporting tab-cel.
Adavosertib Active in Uterine Cancer, But Tolerability Limits Use

1 week ago | targetedonc.com | Sabrina Serani

Adavosertib (AZD1775), an oral Wee1 inhibitor, exhibited some antitumor activity in patients with recurrent or persistent uterine serous carcinoma (USC); however, the treatment's tolerability presented challenges, impacting its overall effectiveness, according to findings from the phase 2b ADAGIO trial (NCT04590248). The study's findings indicated an objective response rate (ORR) of 26.0% of 104 evaluable patients treated with adavosertib.
Daratumumab Plus VMP Shows Sustained Benefit in Transplant-Ineligible Myeloma

1 week ago | targetedonc.com | Sabrina Serani

After more than 7 years of follow-up, daratumumab (Darzalex) plus bortezomib (Velcade), melphalan, and prednisone (D-VMP) continued to demonstrate clinical benefits in patients with transplant-ineligible, newly diagnosed multiple myeloma, bolstering evidence for the efficacy and safety of frontline daratumumab-based therapy, according to the final analysis from the phase 3 ALCYONE study (NCT02195479) published in The Lancet Oncology.1 In ALCYONE, a total of 706 patients were randomized to...
Higher ctDNA Serves as Early Warning for Melanoma Recurrence Risk

1 week ago | targetedonc.com | Sabrina Serani

May 5, 2025David Polsky, MD, discussed a study showing ctDNA levels before melanoma treatment strongly predict recurrence and its speed, potentially guiding future therapy decisions. A new study published in The Lancet and led by NYU Langone Health researchers indicates that the presence of circulating tumor DNA (ctDNA) in stage 3 melanoma patients before treatment is a strong predictor of cancer recurrence.
First-in-Human Data Highlights Potential of Intracellular Checkpoint Inhibition in Metastatic Colorectal Cancer

1 week ago | targetedonc.com | Sabrina Serani

First-in-human data has demonstrated the feasibility and potential efficacy of targeting the intracellular immune checkpoint CISH in patients with heavily pretreated metastatic colorectal cancer.1,2The results were featured in an featured oral presentation at the 2025 American Association for Cancer Research (AACR) Annual Meeting and simultaneously published in The Lancet Oncology and represent a step forward in the pursuit of novel immunotherapeutic strategies for solid tumors.
EVP Before Consolidative Surgery Optimizes Responses in Urothelial Cancer

2 weeks ago | cancernetwork.com | Sabrina Serani

Treatment with enfortumab vedotin (Padcev) plus pembrolizumab (Keytruda; EVP) preceding consolidative surgery shows feasibility, leading to high complete response rates in patients with advanced urothelial carcinoma, according to a retrospective cohort study presented at the American Urological Association (AUA) 2025 Annual Meeting.1Data from this study were presented in a poster at the 2025 American Urological Association (AUA) Annual Meeting.
CBT Benefits Cancer Patients' Mental Health & Treatment Adherence

2 weeks ago | targetedonc.com | Sabrina Serani

Cognitive behavioral therapy (CBT) offers significant benefits for patients with cancer by addressing the emotional and psychological challenges that often accompany a diagnosis and its treatment. Unlike therapies that focus solely on emotions, CBT operates on the principle that thoughts and behaviors significantly influence feelings.