FDA Announces Oncology Center of Excellence
U.S. Food and Drug Administration (FDA)

FDA Announces Oncology Center of Excellence

The U.S. Food and Drug Administration (FDA) recently announced, through the Office of Health and Constituent Affairs, that it has established the Oncology Center of Excellence (OCE). Longtime FDA official, Richard Pazdur, MD, has been named to lead the division as its first director. The OCE will make oncology “the first disease area to have a coordinated clinical review of drugs, biologics and devices across the agency’s three medical product centers,” according to the FDA.

March 02, 2017
Cancer treatments

FDA Approves New Indication for Obinutuzumab

On February 26, 2016, the U. S. Food and Drug Administration approved obinutuzumab (Gazyva® Injection, Genentech, Inc.) for use in combination with bendamustine followed by obinutuzumab monotherapy for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen. Obinutuzumab was previously approved for use in combination with chlorambucil for the treatment of patients with previously untreated chronic lymphocytic leukemia.

February 26, 2016
Cancer treatments

FDA Approves New Ofatumumab Indication

On January 19, 2016, the U.S. Food and Drug Administration approved ofatumumab (Arzerra® Injection, Novartis Pharmaceuticals Corporation) for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL). Ofatumumab was previously approved for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy was considered inappropriate and also for patients with CLL refractory to fludarabine and alemtuzumab.
January 19, 2016
Right-to-try laws to challenge the FDA
Oncology drug research

Growing Number of States Enact Right-to-Try Laws in Challenge to FDA

Investigational drug approval usually takes a long time under the rigorous testing process established by the U.S. Food and Drug Administration. The process is meant to protect patients from possibly useless drugs or drugs that might worsen their condition while providing access for seriously ill patients, such as those with cancer, seeking investigational treatment that may be their only survival option.
January 05, 2016