publication date: Mar. 6, 2015

FDA’s Activism Changes the Landscape In Treatment, Trials of Squamous NSCLC


Citing a dramatic improvement in overall survival in second-line squamous non-small cell lung cancer, FDA rapidly approved the Bristol-Myers Squibb drug Opdivo (nivolumab).

The action, announced March 4, demonstrates the extraordinary activist stance FDA can take when it sees an advantage in overall survival.

In this case, FDA received the data and sprung into action before the results were unblinded to the sponsor, said Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

“With regard to the impetus for this rapid action, we began working immediately on this review and submission strategy after being informed of the survival results. This was prior to BMS having been informed of the results since they were still blinded,” Pazdur said to The Cancer Letter.

The agent, which inhibits the PD-1 cellular pathway, was approved after demonstrating a survival advantage over docetaxel. The drug is approved in the second and third-line indications. This is the second indication for Opdivo, which was previously approved for unresectable or metastatic melanoma in patients who no longer respond to other drugs.

The agency’s handling of Opdivo is consistent with its increasingly activist role in the conduct of clinical trials in oncology. The agency has a seat at the table in the running of the Lung-MAP trial (The Cancer Letter, June 20, 2014).

“Patients and physicians need to be informed about these findings and this was the impetus for the rapid inclusion of the survival data in product labeling,” Pazdur said to The Cancer Letter. … Continue reading 41-09 FDA’s Activism Changes the Landscape In Treatment, Trials of Squamous NSCLC

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