Chris Ryan

Articles

Toripalimab NDA Under Review in Hong Kong for Nasopharyngeal Carcinoma

April 25th 2024

A new drug application seeking the approval of toripalimab for the treatment of patients with nasopharyngeal carcinoma is under review in Hong Kong.

FDA Grants Accelerated Approval to Tovorafenib for Pediatric Relapsed/Refractory BRAF+ Low-Grade Glioma

April 23rd 2024

The FDA granted accelerated approval to tovorafenib for pediatric patients relapsed/refractory low-grade glioma with a BRAF fusion/rearrangement or a BRAF V600 mutation.

FDA Approves Lutetium Lu 177 Dotatate for Pediatric SSTR+ GEP-NETs

April 23rd 2024

The FDA has approved lutetium Lu 177 dotatate for pediatric patients 12 years of age and older with SSTR–positive GEP-NETs.

Health Canada Green Lights Subcutaneous Atezolizumab for Lung, Breast, and Liver Cancer

April 23rd 2024

Health Canada has approved subcutaneous atezolizumab for use in patients with lung cancer, breast cancer, and hepatocellular carcinoma.

VCN-01 Demonstrates Early Efficacy, Safety in Pediatric Refractory Retinoblastoma

April 23rd 2024

VCN-01 was safe and elicited signs of antitumor activity in patients with intraocular retinoblastoma that was refractory to chemotherapy or radiotherapy.

FDA Approves Nogapendekin Alfa Inbakicept Plus BCG for BCG-Unresponsive NMIBC

April 22nd 2024

The FDA has approved nogapendekin alfa inbakicept-pmln plus BCG for BCG-unresponsive non–muscle-invasive bladder cancer with carcinoma in situ with or without papillary tumors.

First-Line Pembrolizumab Plus Chemo Wins Canadian Approval for HER2– Advanced Gastric/GEJ Adenocarcinoma

April 19th 2024

Health Canada has approved pembrolizumab plus chemotherapy for first-line, locally advanced, unresectable, or metastatic, HER2-negative gastric/GEJ cancer.

FDA Approves Adjuvant Alectinib for ALK+ Early-Stage NSCLC

April 18th 2024

The FDA has approved alectinib as adjuvant treatment in select patients with ALK-positive non–small cell lung cancer.

FDA Approves Lumisight and Lumicell DVS for Residual Breast Cancer Detection

April 18th 2024

The FDA has approved the optical imaging agent Lumisight and the Lumicell Direct Visualization System for use in fluorescence imaging in breast cancer.

Serial ctDNA Testing Could Improve Risk Stratification in High-Risk MIBC

April 16th 2024

Serial testing of ctDNA could improve risk stratification for determining adjuvant treatment in patients with high-risk muscle-invasive bladder cancer.

FDA Grants Fast Track Designation to TLX101-CDx for Imaging Progressive/Recurrent Glioma

April 16th 2024

The PET imaging agent TLX101-CDx has received FDA fast track designation for the characterization of progressive or recurrent glioma.

FDA Receives Type C Meeting Request for Pelareorep in HR+/HER2– Metastatic Breast Cancer

April 12th 2024

The FDA has received a type C meeting request from Oncolytics Biotech to discuss a registration-enabling trial for pelareorep in HR+/HER2– breast cancer.

Insider Insights: Unveiling Takeaways from AACR 2024

April 11th 2024

Experts from across the oncology field highlight their biggest takeaways and the hottest topics from the 2024 AACR Annual Meeting.

FDA Grants Accelerated Approval to Trastuzumab Deruxtecan for Unresectable or Metastatic HER2+ Solid Tumors

April 5th 2024

The FDA granted accelerated approval to trastuzumab deruxtecan for pretreated, unresectable or metastatic HER2-positive solid tumors.

VBI-1901 Elicits Disease Control in Recurrent Glioblastoma

April 3rd 2024

The cancer vaccine immunotherapeutic VBI-1901 generated disease control in patients with recurrent glioblastoma.

FDA to Review Zanidatamab BLA for HER2+ Metastatic Biliary Tract Cancer

April 2nd 2024

A rolling BLA for zanidatamab in previously treated, HER2-positive, advanced biliary tract cancer has been submitted to the FDA.

FDA Accepts BLA for Datopotamab Deruxtecan for Pretreated HR+/HER2– Metastatic Breast Cancer

April 2nd 2024

The FDA has accepted a biologics license application for datopotamab deruxtecan in HR-positive, HER2-negative metastatic breast cancer.

China’s NMPA Accepts sBLA for Enfortumab Vedotin Plus Pembrolizumab in Advanced Urothelial Cancer

March 28th 2024

China’s NMPA accepted a sBLA for enfortumab vedotin plus pembrolizumab for the first-line treatment of locally advanced or metastatic urothelial cancer.

Perioperative Pembrolizumab Wins Approval in Europe for Resectable NSCLC at High Risk of Recurrence

March 28th 2024

The European Commission has approved neoadjuvant pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab, for high-risk, resectable NSCLC.

Capivasertib/Fulvestrant Wins Approval in Japan for Advanced HR+/HER2– Breast Cancer With PIK3CA, AKT1, or PTEN Alterations

March 27th 2024

Capivasertib plus fulvestrant has been approved in Japan for pretreated, PIK3CA-, AKT1-, or PTEN-altered, HR-positive, HER2-negative breast cancer.