Chris Ryan

Articles

FDA Grants Breakthrough Device Designation to At-Home Cervical Cancer Screening Test

May 9th 2024

The FDA has granted a breakthrough device designation to Teal Wand, an at-home screening test for cervical cancer.

FDA Grants Orphan Drug Designation to 9MW2821 for Esophageal Cancer

May 8th 2024

The FDA has granted orphan drug designation to 9MW2821 as a potential treatment for patients with esophageal cancer.

Setanaxib Plus Pembrolizumab Improves Survival in Recurrent/Metastatic HNSCC

May 7th 2024

Setanaxib plus pembrolizumab improved progression-free survival and overall survival in recurrent or metastatic head and neck squamous cell carcinoma.

FDA Approves Noninvasive Stool RNA Screening Test for CRC

May 7th 2024

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.

SLS009 Plus Venetoclax/Azacitidine Produces Responses in R/R AML, Including ASXL1+ Disease

May 1st 2024

SLS009 plus venetoclax and azacitidine elicited responses in patients with relapsed/refractory AML, particularly in those harboring ASXL1 mutations.

EVT801 Is Well Tolerated, Elicits Disease Control in Advanced Ovarian Cancer

May 1st 2024

Treatment with EVT801 was well tolerated and led to a stable disease rate of 46% in patients with advanced ovarian cancer.

Glecirasib Generates Durable Responses in Pretreated Advanced KRAS G12C+ NSCLC

April 30th 2024

Glecirasib elicited responses and demonstrated a manageable safety profile in patients with pretreated advanced NSCLC harboring KRAS G12C mutations.

FDA Approves Tisotumab Vedotin for Recurrent or Metastatic Cervical Cancer

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 Improves PFS in Metastatic HR+/HER2-Low Breast Cancer After Endocrine Therapy

April 29th 2024

Trastuzumab deruxtecan improved PFS vs chemotherapy in HR-positive, HER2-low metastatic breast cancer after 1 or more lines of endocrine therapy.

CHMP Recommends Capivasertib/Fulvestrant for Pretreated ER+/HER2– Advanced Breast Cancer With PIK3CA, AKT1, or PTEN Alterations

April 29th 2024

The EMA’s CHMP recommended capivasertib/fulvestrant for ER-positive, HER2-negative advanced breast cancer harboring PIK3CA, AKT1, or PTEN alterations.

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.