It is difficult to completely cure cancers. The prolonging of overall survival (OS) has long been the gold standard for evaluating the efficacy of targeted therapy and drug approval in clinical practice. OS has the advantages of objective evaluation and less influence from investigators’ observation bias, but it also has the disadvantage of long observation time and being easily affected by later-line therapies. The U.S. Food and Drug Administration (FDA) determined the improvement of OS as the main evaluation index in the standard drug approval process in 2017. However, if a drug is intended to treat a serious life-threatening disease and can provide significant improvement in the disease or fill the treatment gap, it can enter the accelerated approval pathway under certain conditions and adopt surrogate endpoints to support drug approval. The surrogate endpoints recommended by the U.S. FDA in clinical trials of new drugs include progression-free survival (PFS), time to progression, event-free survival, objective response rate (ORR), complete response (CR), disease-free survival, and time to treatment failure. Among these recommended outcome indexes, the surrogate endpoint of PFS is more relevant to OS. PFS as a trial endpoint has the advantage of short observation time and small sample size required for the study. The disadvantage of PFS is derived from its subjectivity, which is prone to cause evaluation bias, and difficult to determine the direct impact on patient survival. Considering the lack of objectivity of the surrogate endpoints, the National Medical Products Administration has established relatively strict approval criteria for new drugs. The Guidelines on General Considerations for Clinical Trials of Drugs issued by the National Medical Products Administration in 2017 pointed out that the primary endpoint of a clinical trial should reflect the primary clinical effects of the drug and should be selected based on the primary purpose of the study. Surrogate endpoints are indexes related to primary endpoints but are not direct evidence of clinical benefits themselves. A surrogate endpoint can be used as a primary index only when it is highly likely or known to be reasonably predictive of the primary endpoint. Therefore, survival benefit is still the main supporting basis for molecular targeted drugs approval by the National Medical Products Administration.