Tipifarnib Gets Breakthrough Tx Designation for Head and Neck Cancer
The FDA previously granted Fast Track designation to tipifarnib for this indication.
The FDA previously granted Fast Track designation to tipifarnib for this indication.
This month we look at a case where a jury was asked to hold a patient partially responsible for his own injury based on the fact that he had some medical background.
The accelerated approval was based on data from a prospectively-planned retrospective analysis of 10 cohorts of patients with various previously treated unresectable or metastatic solid tumors with TMB-H who were enrolled in the open-label phase 2 KEYNOTE-158 trial.
The FDA has approved an expanded indication for Gardasil 9® (human papillomavirus 9-valent vaccine [HPV], recombinant; Merck) to include the prevention of oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58 in patients aged 9 to 45 years.
The FDA has approved the supplemental Biologics License Application (sBLA) for Keytruda® (Merck) to include an additional recommended dosage of 400mg every 6 weeks across all adult indications.
Nonurgent appointments should be postponed; use of telemedicine encouraged when feasible.
Pfizer announced the launch of 3 new biosimilars: Zirabev (bevacizumab-bvzr), Ruxience (rituximab-pvvr) and Trazimera (trastuzumab-qyyp). Zirabev, a biosimilar to Avastin (bevacizumab; Genentech), is available for the treatment of 5 types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma; and persistent, recurrent…
The Food and Drug Administration (FDA) has granted Orphan Drug Designation to zotiraciclib (Adastra Pharmaceuticals) for the treatment of glioma.
The Food and Drug Administration (FDA) has granted accelerated approval to Rozlytrek (entrectinib; Genentech)
Statin use tied to reduction in stroke incidence for cardiac patients with thorax and head or neck cancer