FDA declines to approve Merck and Eisai’s liver cancer combo therapy

The U.S. drug regulator declined to approve a combination of Merck & Co Inc’s blockbuster cancer drug Keytruda and Eisai Co Ltd’s Lenvima as the first line of treatment in patients with liver cancer, the companies said on Wednesday.

The Food and Drug Administration’s complete response letter cited lack of sufficient evidence that the combination therapy had a meaningful advantage over available treatments for the condition, the companies said.

The companies said they plan to conduct a clinical trial to demonstrate substantial evidence of the combination’s effectiveness in liver cancer.

Merck and Eisai are continuing to evaluate Keytruda in combination with Lenvima across 13 different types of tumor in 18 trials.

The FDA letter will not impact the indications Keytruda and Lenvima are already approved for, the companies said.

https://www.reuters.com/article/us-merck-co-fda-eisai/fda-declines-to-approve-merck-and-eisais-liver-cancer-combo-therapy-idUSKBN2491M8