FDA Rejects Eli Lilly’s China-Developed Cancer Drug

Lilly said it is assessing next steps for the immunotherapy, named Tyvyt, in the U.S. Morgan Stanley analysts said in a research note they don’t expect Lilly to continue developing the drug for the U.S. because of the high cost and long timeline for the additional study the FDA requested.

Also, the analysts said, the study would run the risk of showing that Tyvyt is inferior to the market leader for treatment of non-small-cell lung cancer, Merck & Co.’s Keytruda.

Lilly shares rose nearly 1% in early trading.

The rejection underscores new FDA concerns about a wave of drugs that are being tested only or predominantly in China, which Chinese companies, sometimes in collaboration with Western drugmakers, hope to sell in the U.S.

Regulators have questioned the quality of studies conducted in China, and whether the results of such testing can apply to patients in the U.S.

FDA officials have said they plan to scrutinize such drugs, and have urged companies to conduct drug trials in several countries rather than just in China. FDA officials have said there may be differences between countries in medical care and population that affect how a drug performs.

In February, a panel advising the FDA voted 14-1 to recommend additional studies be conducted for Tyvyt, a drug that Indianapolis-based Lilly has co-developed with China-based Innovent Biologics Inc., which discovered it.

At the February hearing, FDA officials said there were significant shortcomings in how Tyvyt was tested in a Chinese study, and said the results on benefits and risks weren’t applicable to U.S. patients.

Lilly had been planning to introduce Tyvyt as a treatment for non-small-cell lung cancer at a lower price than comparable treatments in the U.S., such as Merck’s Keytruda and Bristol-Myers Squibb Co. ’s Opdivo.

Lilly said the FDA recommended an additional clinical study, specifically one conducted in multiple regions, and which compares Tyvyt with standard treatment and tracks overall survival of patients.

Previously, Innovent conducted a trial of Tyvyt in China and found that combining it with chemotherapy prolonged the median time to disease progression or death to about 8.9 months, versus five months for those on chemotherapy alone.

Write to Peter Loftus at [email protected]