Kristi Rosa

Articles

Drug Combo Improves PFS in mCRPC

May 03, 2021

The novel oral TKI masitinib in combination with docetaxel and prednisone resulted in improved progression-free survival compared with docetaxel plus prednisone in patients with metastatic castration-resistant prostate cancer, meeting the predefined primary end point of the phase 2b/3 AB12003 trial.

Adjuvant Nivolumab Granted Priority Review for Muscle-Invasive Urothelial Carcinoma

May 02, 2021

The FDA has granted a priority review designation to a supplemental biologics license application for nivolumab for use as an adjuvant treatment in patients with surgically resected, high-risk, muscle-invasive urothelial carcinoma.

FDA Authorizes Marketing for AI Colon Cancer Detection Device

April 12, 2021

The FDA has authorized the marketing of the first device that utilizes artificial intelligence based on machine learning to help clinicians detect lesions like polyps or suspected tumors in the colon in real time during a colonoscopy.

FDA Approves Additional Cetuximab Dose for KRAS Wild-Type, EGFR-Expressing CRC, Head and Neck Cancer

April 07, 2021

The FDA has approved a new biweekly dosing regimen of 500 mg/m2 as a 120-minute intravenous infusion for cetuximab (Erbitux) for patients with KRAS wild-type, EGFR-expressing colorectal cancer or squamous cell carcinoma of the head and neck.

NCCN Updates Clear Cell RCC Guidelines

April 03, 2021

The National Comprehensive Cancer Network has updated its Clinical Practice Guidelines to include tivozanib as a recommended regimen for subsequent therapy in patients with clear cell renal cell carcinoma.

Futibatinib Granted Breakthrough Therapy Designation for FGFR2+ Advanced Cholangiocarcinoma

April 02, 2021

The FDA has granted a breakthrough therapy designation to the FGFR inhibitor futibatinib for the treatment of patients with previously treated, locally advanced or metastatic cholangiocarcinoma that harbors FGFR2 gene rearrangements, including fusions.