FDA granted Fast Track designation to PDS0101 in combination with Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) for the treatment of recurrent or metastatic HPV16-positive head and neck cancer.
In a letter addressed to FDA Commissioner Robert Califf, Republican leaders of the House Committee on Energy and Commerce and two of its subcommittees raised questions about the increasing number of clinical trials conducted in China by companies seeking FDA approval for “me-too” checkpoint inhibitor drugs.
FDA granted marketing authorization to the Parsortix System for the harvesting of circulating cancer tumor cells in metastatic breast cancer.
FDA approved a combination of Tibsovo (ivosidenib) and Vidaza (azacitidine) for the treatment of patients with newly diagnosed IDH1-mutant acute myeloid leukemia who are 75 years or older or with comorbidities that prevent the use of induction chemotherapy.
An analysis conducted by Friends of Cancer Research showed that the FDA Breakthrough Therapy Designation criteria select drugs that lead to better outcomes for patients with lung cancer.
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.
