Chris Ryan

Articles

FDA Approves Capivasertib Plus Fulvestrant in Advanced HR+/HER2– Breast Cancer With PIK3CA, AKT1, or PTEN Alterations

November 16th 2023

The FDA has approved capivasertib plus fulvestrant for the treatment of patients with HR-positive, HER2-negative, locally advanced or metastatic breast cancer harboring 1 or more PIK3CA, AKT1, or PTEN alterations, following progression on at least 1 endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.

FDA Approves First-Line Pembrolizumab Plus Chemotherapy for Unresectable HER2– Gastric/GEJ Adenocarcinoma

November 16th 2023

The FDA has approved pembrolizumab in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic, HER2-negative gastric or gastroesophageal junction adenocarcinoma.

Trastuzumab Deruxtecan Demonstrates Real-World Intracranial Efficacy in Metastatic HER2+ Breast Cancer

November 14th 2023

Data from a real-world study in Japan showed that fam-trastuzumab deruxtecan-nxki displayed intracranial efficacy in patients with HER2-positive breast cancer harboring brain metastases and/or leptomeningeal carcinomatosis.

FG001 Meets Detection End Point in High-Grade Glioma

November 14th 2023

The use of the optical imaging agent FG001 led to the detection of additional cancer by optical guidance in patients with high-grade glioma, meeting the primary end point of the phase 2b FG001-CT-001 trial.

PV-10 Elicits Hepatic Responses in Uveal Melanoma With Liver Metastases

November 13th 2023

Treatment with the novel immunotherapy PV-10 led to hepatic responses in patients with metastatic uveal melanoma with liver metastases, according to updated data from a phase 1 trial.

Deeper Understanding of Clonal Hematopoiesis Could Improve Cardiovascular Outcomes for Patients With Kidney Cancer

November 11th 2023

Additional research exploring the association between clonal hematopoiesis and cardiovascular health could help improve outcomes for patients with kidney cancer and identify those at higher risk for experiencing cardiac events.

Enfortumab Vedotin Plus Pembrolizumab Has Potential to Alter SOC in Frontline Urothelial Cancer

November 10th 2023

The combination of enfortumab vedotin-ejfv plus pembrolizumab represents a chemotherapy-free regimen that could alter the standard of care in the frontline treatment of all patients with metastatic urothelial carcinoma.

Unique Molecular Profiles of Biliary Tract Cancers Drive Continued Development of Targeted Therapies

November 9th 2023

The mitigation and management of toxicities is a key component of treating patients with biliary tract cancers with targeted therapies.

Data Continue to Refine Frontline BTK Inhibitor Selection in CLL

November 8th 2023

Along with the combination of venetoclax and obinutuzumab, the BTK inhibitor–based regimens of zanubrutinib monotherapy and acalabrutinib plus obinutuzumab represent the preferred options in the National Comprehensive Cancer Network Guidelines for the first-line treatment of patients with chronic lymphocytic leukemia without 17p deletions or TP53 mutations.

Domvanalimab Plus Zimberelimab and Chemotherapy Elicits Responses in Advanced Gastric/GEJ Adenocarcinoma

November 7th 2023

The combination of domvanalimab, zimberelimab, and FOLFOX elicited responses in patients with locally advanced unresectable or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma, irrespective of PD-L1 status.

Frontline Cadonilimab Plus Chemotherapy Improves OS in Advanced Gastric/GEJ Adenocarcinoma

November 7th 2023

First-line treatment with the PD-1/CTLA-4 bispecific antibody cadonilimab in combination with oxaliplatin and capecitabine led to a statistically significant improvement in overall survival vs placebo plus oxaliplatin and capecitabine in patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma, meeting the primary end point of the phase 3 AK104-302 trial.

FDA Accepts IND for Novel CDH17-Targeted CAR T-Cell Therapy for Advanced Gastrointestinal Cancers

November 6th 2023

The FDA has cleared the investigational new drug application for CHM 2101, a novel CDH17-targeted CAR T-cell therapy, for the treatment of patients with gastrointestinal cancers.

Panitumumab Plus FOLFIRINOX or mFOLFOX6 Elicits Similar Responses in RAS/BRAF V600E Wild-Type Unresectable mCRC

November 6th 2023

The addition of panitumumab to FOLFIRINOX or mFOLFOX6 led to comparable overall response rates and complete response rates in patients with RAS or BRAF V600E wild-type, unresectable, metastatic colorectal cancer without liver-limited disease.

FDA Grants Orphan Drug Designation to AL102 in Desmoid Tumors

November 6th 2023

The FDA has granted an orphan drug designation to AL102 as a potential therapeutic option for patients with desmoid tumors.

Role of Radiation Continues to Grow in the Treatment of Prostate Cancer

November 3rd 2023

Improved toxicity, advanced technology, and novel techniques have helped increase the use of radiotherapy for the treatment of different subgroups of patients with prostate cancer.

EU Approval Sought for Encorafenib/Binimetinib in BRAF V600+ Advanced NSCLC

November 2nd 2023

The European Medicines Agency had validated a marketing authorization application seeking the approval of the combination of encorafenib and binimetinib for the treatment of adult patients with BRAF V600–mutant advanced non–small cell lung cancer.

Adjuvant Pembrolizumab Improves OS in Select Patients With RCC After Nephrectomy

November 1st 2023

Adjuvant treatment with pembrolizumab significantly improved overall survival vs placebo in patients with renal cell carcinoma at intermediate-high or high risk of recurrence after nephrectomy, or after nephrectomy and resection of metastatic lesions, meeting a key secondary end point of the phase 3 KEYNOTE-564 trial.

FDA Grants Fast Track Designation to SLS009 for Relapsed/Refractory PTCL

October 31st 2023

The FDA has granted a fast track designation to SLS009 for the treatment of patients with relapsed/refractory peripheral T-cell lymphoma.

VAL-083 Fails to Outperform SOC in Glioblastoma

October 31st 2023

VAL-083 did not improve efficacy compared with standard-of-care approaches in patients with glioblastoma.

FDA Grants Priority Review to Tovorafenib in Pediatric Relapsed/Progressive Low-Grade Glioma

October 30th 2023

The FDA has granted priority review to a new drug application seeking the approval of tovorafenib monotherapy for the treatment of pediatric patients with relapsed or progressive low-grade glioma.