Tipifarnib Gets Breakthrough Tx Designation for Head and Neck Cancer
The FDA previously granted Fast Track designation to tipifarnib for this indication.
Head and Neck Cancer
Physician Overlooks MRI, Then Claims Chiropractor Patient Should Have Read It
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.
FDA Approves Keytruda for Tumor Mutational Burden-High Cancer
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.
Gardasil 9 Approved to Prevent Certain HPV-Related Head and Neck Cancers
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.
New Dosing Schedule Approved for All Keytruda Indications
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.
Guidelines Developed for Head and Neck Care During COVID-19
Nonurgent appointments should be postponed; use of telemedicine encouraged when feasible.
Pfizer Announces Launch of Three Biosimilar Cancer Treatments
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…
Orphan Designation Granted to Zotiraciclib for Glioma
The Food and Drug Administration (FDA) has granted Orphan Drug Designation to zotiraciclib (Adastra Pharmaceuticals) for the treatment of glioma.
Rozlytrek, a Tumor Agnostic Therapy, Receives FDA Approval
The Food and Drug Administration (FDA) has granted accelerated approval to Rozlytrek (entrectinib; Genentech)
Statins May be Beneficial After Radiation to Thorax, Head, Neck
Statin use tied to reduction in stroke incidence for cardiac patients with thorax and head or neck cancer
