May 9th 2024
The FDA has granted a breakthrough device designation to Teal Wand, an at-home screening test for cervical cancer.
May 8th 2024
The FDA has granted orphan drug designation to 9MW2821 as a potential treatment for patients with esophageal cancer.
May 7th 2024
Setanaxib plus pembrolizumab improved progression-free survival and overall survival in recurrent or metastatic head and neck squamous cell carcinoma.
The FDA has approved ColoSense for use as a screening test in adults 45 years of age or older who are at average risk of developing colorectal cancer.
May 1st 2024
SLS009 plus venetoclax and azacitidine elicited responses in patients with relapsed/refractory AML, particularly in those harboring ASXL1 mutations.
Treatment with EVT801 was well tolerated and led to a stable disease rate of 46% in patients with advanced ovarian cancer.
April 30th 2024
Glecirasib elicited responses and demonstrated a manageable safety profile in patients with pretreated advanced NSCLC harboring KRAS G12C mutations.
April 29th 2024
The FDA granted full approval to tisotumab vedotin for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
Trastuzumab deruxtecan improved PFS vs chemotherapy in HR-positive, HER2-low metastatic breast cancer after 1 or more lines of endocrine therapy.
The EMA’s CHMP recommended capivasertib/fulvestrant for ER-positive, HER2-negative advanced breast cancer harboring PIK3CA, AKT1, or PTEN alterations.
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.