We wish to applaud the sentiments expressed in the recent article in The Cancer Letter titled “Oncologists, advocates, FDA call for an end to MTD and ‘more is better’ era in cancer drug dosing,” but also raise several concerns to be addressed as this initiative moves forward.
FDA is asking sponsors of all investigational medical products to focus on including diverse patients throughout the clinical development process.
Getting the dose right is not a mere formality but a fundamentally important first step that can mean the difference between success and failure of a drug development program, Richard Pazdur, director of the FDA Oncology Center of Excellence, said at a workshop focused on the issue of dose optimization.
In the trenches on the medicine wards and smoking cessation clinics at Parkland Hospital and UT Southwestern Simmons Cancer Center, I see firsthand the increased prevalence of smoking in the Black population, their frequent use of menthol, and the ravaging toll it takes on their health.
For decades, pinpointing the highest dose of a drug that cancer patients could tolerate was the first step investigators were required to take before moving into phase II and III clinical trials.
FDA has announced proposed product standards that would prohibit menthol as a characterizing flavor in cigarettes and prohibit all characterizing flavors other than tobacco in cigars.
FDA granted clearance to version 1.1 of the next generation SmartFrame Array Neuro Navigation System and Software, sponsored by ClearPoint Neuro Inc.
A commentary authored by seven researchers who participated in the FDA Oncology Center of Excellence “Conversations on Cancer,” held July 29, 2021, discussed the significant cancer disparities facing Asian Americans.
FDA accepted the supplemental Biologics License Application of Enhertu (fam-trastuzumab deruxtecan-nxki), a HER2-directed antibody drug conjugate, for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer whose tumors have a HER2 (ERBB2) mutation and who have received a prior systemic therapy. The application has also been granted Priority Review.
Why is the April 21 ODAC different from all the other ODACs? At all other ODACs, a commercial sponsor gets to make a case. On April 21, only FDA’s voice will be heard.
