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.
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.
The FDA has approved lutetium Lu 177 dotatate for pediatric patients 12 years of age and older with SSTR–positive GEP-NETs.
Health Canada has approved subcutaneous atezolizumab for use in patients with lung cancer, breast cancer, and hepatocellular carcinoma.
VCN-01 was safe and elicited signs of antitumor activity in patients with intraocular retinoblastoma that was refractory to chemotherapy or radiotherapy.
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.
April 19th 2024
Health Canada has approved pembrolizumab plus chemotherapy for first-line, locally advanced, unresectable, or metastatic, HER2-negative gastric/GEJ cancer.
April 18th 2024
The FDA has approved alectinib as adjuvant treatment in select patients with ALK-positive non–small cell lung cancer.
The FDA has approved the optical imaging agent Lumisight and the Lumicell Direct Visualization System for use in fluorescence imaging in breast cancer.
April 16th 2024
Serial testing of ctDNA could improve risk stratification for determining adjuvant treatment in patients with high-risk muscle-invasive bladder cancer.
The PET imaging agent TLX101-CDx has received FDA fast track designation for the characterization of progressive or recurrent glioma.
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.
April 11th 2024
Experts from across the oncology field highlight their biggest takeaways and the hottest topics from the 2024 AACR Annual Meeting.
April 5th 2024
The FDA granted accelerated approval to trastuzumab deruxtecan for pretreated, unresectable or metastatic HER2-positive solid tumors.
April 3rd 2024
The cancer vaccine immunotherapeutic VBI-1901 generated disease control in patients with recurrent glioblastoma.
April 2nd 2024
A rolling BLA for zanidatamab in previously treated, HER2-positive, advanced biliary tract cancer has been submitted to the FDA.
The FDA has accepted a biologics license application for datopotamab deruxtecan in HR-positive, HER2-negative metastatic breast 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.
The European Commission has approved neoadjuvant pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab, for high-risk, resectable NSCLC.
March 27th 2024
Capivasertib plus fulvestrant has been approved in Japan for pretreated, PIK3CA-, AKT1-, or PTEN-altered, HR-positive, HER2-negative breast cancer.