publication date: Nov. 11, 2016

Conversation with The Cancer Letter FDA Eager to Approve PD-1 and PD-L1 Drugs in Novel Combinations, New Settings  

In an in-depth interview with The Cancer Letter, an FDA official clarified the agency’s criteria for approval of drugs that target PD-1 and PD-L1.

Last month, The Cancer Letter reported that there are 803 registered clinical trials testing 20 PD-1 and PD-L1 drugs. These trials have slots for 166,736 patients. (The Cancer Letter, Oct. 7).

The scope of this development effort appears to be unprecedented.

“We are not aware of a precedent for this magnitude of development of agents targeting a specific pathway in oncology; for example, there are three approved monoclonal antibodies targeting VEGF/VEGFR signaling approved in oncology, and eight approved small molecule kinase inhibitors that inhibit VEGFR signaling for a multitude of different cancer types,” said Gideon Blumenthal, lead medical officer, Office of Hematology and Oncology Products, FDA Center for Drug Evaluation and Research.

“Whether the clinical and commercial needs across oncology exist to support the development of 20 or more of these drugs is an open question.”

These drugs appear to be similar, Blumenthal said.

“We in the cancer community have to be smart in how we test novel agents in patients,” he said.

“There are differences in these PD-1 and PD-L1 inhibitors, including the specific protein that these antibodies target, the immunoglobulin subclass (e.g. IgG1 versus IgG4), … Continue reading FDA Eager to Approve PD-1 and PD-L1 Drugs in Novel Combinations, New Settings

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