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# FDA 2016 Oncology Approvals Touted
- URL: https://www.fdaweb.com/fda-2016-oncology-approvals-touted/
- Published: 2017-02-22T12:00:00.000Z
- Updated: 2026-09-14T22:08:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138039

CDER oncology drug senior staffers **Richard Pazdur** and **Gideon Blumenthal** review FDA’s 2016 oncology drug approvals in a *Clinical Oncology* commentary. They [note](http://www.nature.com/nrclinonc/journal/v14/n3/full/nrclinonc.2017.12.html?WT.feed%5Fname=subjects%5Fcancer&ref=fdaweb.com) the approval of five new molecular entities and 17 efficacy supplements, including six accelerated approvals, 17 priority reviews, and 11 approvals of breakthrough-designated therapies. The agency also approved five companion diagnostics, they say, including a liquid biopsy test. One new anti-PD-L1 antibody was approved, along with six supplementary approvals of anti-PD-L1 antibodies.

“In the coming years,” the two write, “we are likely to see the continued expansion of the therapeutic landscape of immune checkpoint inhibitors, targeted therapies, and novel companion and complementary diagnostics, including the further development of multiplex genomic testing platforms…. Short-term and longer-term FDA oncology priorities include the use of ‘real-world evidence’ to enable evidence generation outside of clinical trials…. Other FDA oncology priorities include facilitating a culture of data sharing to ensure that clinical trial data that currently exist in silos can more broadly be used by the biomedical community to rapidly translate basic and clinical observations to improve patient care. Also, FDA will continue to support the expansion of patient eligibility criteria in oncology clinical trials, thus improving generalizability and access to trials while ensuring public safety.”