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  • Bavencio, difficulty in expanding indication
  • by | translator Choi HeeYoung | Dec 11, 2020 06:16am
Primary endpoint OS verification failure
The presence of alternative/follow-up treatment also affects
Will conclusions be different from Europe and the United States?
The possibility of approval for a renal cell carcinoma indication for Bavencio(Avelumab), an immunotherapy developed by Merck and Pfizer, is very low. This is because the Central Pharmaceutical Affairs Review Committee of the MFDS has not recognized Bavencio's therapeutic effect.

The Central Pharmaceutical Affairs Review Committee held a meeting on October 29th, when Merck and Pfizer applied for Bavencio's indications for renal cell carcinoma, and whether the results of the clinical trials submitted were recognized as the agenda.

According to the results of the minutes released on the 9th, none of the six members who attended the meeting did not acknowledge the validity of Bavencio. The committee members were ci
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