Sintilimab as a Cost-Effective Alternative for Nonsquamous NSCLC

Jorge Nieva, MD, associate professor of Clinical Medicine at the Keck School of Medicine of University of Southern California, discusses the recent biologics license application for sintilimab (Tyvyt) injection in combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with nonsquamous non–small cell lung cancer (NSCLC), and why he voted differently from the other members of the FDA’s Oncologic Drug Advisory Committee in a recent meeting.

The committee voted was 14 to 1 in favor of more research to support a future FDA approval for the sintilimab combination during a February meeting due to concerns about the validity of data from a 100% Asian population conducted in China and designed with a primary end point of progression-free survival.

Nieva explains that sintilimab may have offered a solution to the ongoing problem of cost prohibitive drugs developed for patients in the United State.

Transcription:

0:08 | I am concerned about the cost of drugs in the United States. And the FDA is description of how they view ideal drug development with a multi-regional trial model looks to me to be a very expensive way of doing trials. It requires global firms. And I think if we raise the bar too high on developing drugs, we're only going to be left with very expensive drugs.

0:51 | This particular drug was going to come to the market at a significant discount compared to current alternatives, perhaps 40 or 50% of the price of the current drugs. And I think the biggest barrier to care in the US, for lung cancer patients is access to these very expensive medications.