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Original New Drug Application Approvals by US FDA (16-31 March 2025)

10 Apr 2025

New drug applications approved by US FDA as of 16-31 March 2025 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

Original New Drug Application Approvals by US FDA (16-31 March 2025)

10 Apr 2025

Elacestrant shows promising antitumour activity in early breast cancer

07 Apr 2025

Preoperative treatment with the oral nonsteroidal selective ER degrader elacestrant appears to yield biological and molecular responses in early-stage breast cancer, while having a manageable safety profile, as shown in a phase I trial.

Elacestrant shows promising antitumour activity in early breast cancer

07 Apr 2025

Is vitiligo as side effect a good sign for cancer patients on immunotherapy?

03 Apr 2025 by

Vitiligo occurs as a cutaneous immune-related adverse event during immune checkpoint inhibitor (ICI) therapy in most melanoma and nonmelanoma cancer patients with partial or complete response to treatment, according to a systematic review.

Is vitiligo as side effect a good sign for cancer patients on immunotherapy?

03 Apr 2025

EGFR gene mutation abundance predicts survival in NSCLC patients

03 Apr 2025

In patients with nonsmall cell lung cancer (NSCLC), plasma epidermal growth factor receptor (EGFR) mutation abundance shows a significant association with survival benefit, reveals a study.

EGFR gene mutation abundance predicts survival in NSCLC patients

03 Apr 2025

Delayed motherhood poses thyroid cancer risk

03 Apr 2025

Women who gave birth to their first child at an older age face an increased risk of thyroid cancer development, according to an analysis of Asian cohort studies.

Delayed motherhood poses thyroid cancer risk

03 Apr 2025

Cetuximab linked to pocket infections after central venous port placement

02 Apr 2025

Cetuximab therapy appears to induce skin complications in patients following central venous port placement, reports a study.

Cetuximab linked to pocket infections after central venous port placement

02 Apr 2025

What’s new in advanced urothelial carcinoma?

02 Apr 2025 by

Enfortumab vedotin and pembrolizumab’s (EV+P) EV-302 trial results represent a major advancement in metastatic urothelial carcinoma (mUC), including in Asian patients, according to Professor Ravindran Kanesvaran of the National Cancer Centre in Singapore, who also discussed managing skin toxicity associated with this regimen and provided an overview of other agents for UC under investigation at Uro-Oncology Asia 2025.

What’s new in advanced urothelial carcinoma?

02 Apr 2025

Better NPC risk stratification with identification of distinct EBV DNA molecular features

01 Apr 2025 by

A research team from the Faculty of Medicine, Chinese University of Hong Kong (CUHK) has identified molecular features in Epstein-Barr virus (EBV) DNA specifically associated with nasopharyngeal cancer (NPC) that differ significantly from the EBV DNA found in individuals with general EBV infections.

Better NPC risk stratification with identification of distinct EBV DNA molecular features

01 Apr 2025

Clinical insights and updates on use of tislelizumab in advanced ESCC

31 Mar 2025 by

The prognosis of oesophageal squamous cell carcinoma (ESCC) is very poor and treatment options are limited, especially for patients with recurrent or advanced disease. At an industry-sponsored symposium organized by the Hong Kong Society of Clinical Oncology (HKSCO), Professor Beung-Chul Ahn of the National Cancer Centre in Seoul, Korea, presented research data and clinical insights on the use of tislelizumab immunotherapy for advanced ESCC in both second-line and first-line settings.

Clinical insights and updates on use of tislelizumab in advanced ESCC

31 Mar 2025

Pembrolizumab plus lenvatinib: A standard of care in first-line treatment of advanced RCC

31 Mar 2025 by

Therapeutic advancements based on immuno-oncology (IO) combinations have revolutionized the treatment landscape for renal cell carcinoma (RCC). In particular, front-line use of immune checkpoint inhibitors combined with tyrosine kinase inhibitors (TKIs) offers superior survival benefits compared with TKI monotherapy or IO-IO combinations. At the 10^th Annual Scientific Meeting of the Hong Kong Society of Uro-Oncology (HKSUO) (Uro- Oncology Asia 2025), Professor Viktor Grünwald of the University Hospital Essen, Essen, Germany, presented recent data supporting the broad antitumour activity of pembrolizumab plus lenvatinib in patients with clear- and non-clear-cell RCC histologies.

Pembrolizumab plus lenvatinib: A standard of care in first-line treatment of advanced RCC

31 Mar 2025

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Original New Drug Application Approvals by US FDA (16-31 March 2025)

Original New Drug Application Approvals by US FDA (16-31 March 2025)

Elacestrant shows promising antitumour activity in early breast cancer

Elacestrant shows promising antitumour activity in early breast cancer

Is vitiligo as side effect a good sign for cancer patients on immunotherapy?

Is vitiligo as side effect a good sign for cancer patients on immunotherapy?

EGFR gene mutation abundance predicts survival in NSCLC patients

EGFR gene mutation abundance predicts survival in NSCLC patients

Delayed motherhood poses thyroid cancer risk

Delayed motherhood poses thyroid cancer risk

Cetuximab linked to pocket infections after central venous port placement

Cetuximab linked to pocket infections after central venous port placement

What’s new in advanced urothelial carcinoma?

What’s new in advanced urothelial carcinoma?

Better NPC risk stratification with identification of distinct EBV DNA molecular features

Better NPC risk stratification with identification of distinct EBV DNA molecular features

Clinical insights and updates on use of tislelizumab in advanced ESCC

Clinical insights and updates on use of tislelizumab in advanced ESCC

Pembrolizumab plus lenvatinib: A standard of care in first-line treatment of advanced RCC

Pembrolizumab plus lenvatinib: A standard of care in first-line treatment of advanced RCC