Home >> Industry News >> RTOR: FDA's latest convenience service
Yesterday, the FDA corrected the combination of anti-PD-1 Keytruda/Chemotherapy in the approval of first-line non-small cell lung cancer (NSCLC), which had been listed under one of the FDA's policy of facilitating people and accelerating approval. According to the results of KN189 test, this combination was officially approved because it reduced the risk of death or progression by 51% compared with chemotherapy alone. The approval is based on a new FDA trial policy called Real-Time Oncology Review (RTOR). The FDA has obtained all the data and evaluated them before the manufacturer's formal application, thus further shortening the approval time for new drugs.


According to the information on the FDA website, this policy is a pilot policy proposed by the FDA Department of Oncology and Drugs, not a formal policy. It is also not suitable for all indications, limited to drugs for tumors and hematological diseases. Even in this narrow indication drug, it should be shown that standard therapy can be significantly improved, clinical trial design is simple, and the end point is clear. Applications requiring additional CMC, pharmacology, toxicology or design, and complex interpretation are not covered by this policy. If the FDA considers that your drug meets RTOR criteria, the manufacturer can provide key raw data and analysis to the FDA 2-4 weeks after the test data is entered into the database and locked. When the manufacturer formally applies, the FDA may have completed the review and approved it immediately. Last month, Novartis's combination of CDK4/6 inhibitors and aromatase inhibitors was the first approved drug for this policy, but in 2015, it took only four working days to approve the Squamous Non-small Cell Lung Cancer drug Opdivo, which was basically an immediate approval.

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