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FDA, as expected, rejects Lilly and Innovent immunotherapy in signal to drugmakers

Dive Brief:

  • The Food and Drug Administration has rejected an experimental cancer immunotherapy Eli Lilly and partner Innovent Biologics have been developing for a common type of lung cancer, in a decision meant to deter drugmakers from relying on clinical tests exclusively performed in China.


  • The FDA has asked Eli Lilly and Innovent to run an additional, international clinical trial evaluating sintilimab against standard care for newly diagnosed non-small cell lung cancer, a position the agency made clear before an advisory panel meeting in February and a group of outside experts largely supported.


  • In a Thursday statement, Lilly and Innovent said they are “assessing next steps” in the U.S. for sintilimab, which is sold in China as Tyvyt for a type of lymphoma. Lilly has invested heavily in the drug through a longstanding alliance with Innovent and is currently testing it in multiple tumor types.

Dive Insight:

Though expected following a decisive advisory meeting in February, the FDA’s rejection of sintilimab could have important repercussions for drugmakers as well as the costs of cancer immunotherapies in the U.S.

An increasing number of drugmakers have been relying on clinical trials conducted exclusively in China as a way to speed therapies to the U.S. market. Lilly and Innovent’s application for sintilimab in lung cancer was a test of the FDA’s view, and the agency has made its assessment resoundingly clear.

Leading up to the February meeting, the FDA’s top cancer drug evaluator Richard Pazdur co-authored two articles in leading medical journals outlining problems with the data supporting several of those drugs, among them sintilimab. The gathering was a public forum for that message, as the agency and its outside advisers criticized Lilly and Innovent for not enrolling a diverse enough population for the results to be applicable to U.S. patients.

Pazdur, specifically, called such single-country trials “a step backward.” Panelists agreed and voted 14 to 1 for Lilly and Innovent to conduct an additional, more rigorous study.

The FDA has now followed through with a rejection and, notably, asked Lilly and Innovent to test their drug against stronger competition. In lung cancer, that would mean sintilimab going up against an approved, rival immunotherapy, a type of study that the industry hasn’t yet performed. Sintilimab would have to show it can keep patients alive at least as long as standard care in the trial, meaning the study would likely involve thousands of patients and take years to complete. The partners haven’t yet made a decision to move forward, though some analysts have previously speculated that Lilly would balk at such a request.

The FDA’s decision has implications for others following in Lilly’s footsteps. One of them, EQRx, has said it plans to start a head-to-head trial testing its drug sugemalimab against an approved immunotherapy this year, which could ease the FDA’s concerns. But that study would also take years to read out.

In the meantime, the rejection of sintilimab has likely cost the U.S. its most immediate chance to lower the prices of immunotherapies, many of which have annual list prices of more than $150,000 and are contributing to substantial out-of-pocket costs for patients. Lilly has said it planned to price sintilimab, if approved, roughly 40% lower than similar marketed drugs. “We had hoped that sintilimab could have played a positive role for patients and the U.S. healthcare system through an aggressive pricing strategy,” the company said in a statement after the hearing in February.

The FDA has countered that it’s not supposed to factor prices into its decisions. But the lone committee member who dissented in February, University of Southern California oncologist Jorge Nieva, worried that the standard the agency would set by ignoring price and rejecting sintilimab might backfire.

“I’m concerned that if we don’t allow these types of trials for me-too drugs, we’re going to be limited in our ability to have more drugs for our patients, and that’s going to lead to higher costs in general for them,” he said.