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작성자 : admin작성일 : 2019-06-29 13:05

타사 탑 라인 지연 이후 FDA승인 기록 주요 사례

Major Target agent approval history including failed Phase III

1. Ramucirumab (Cyramza): anti-VEFR-2
1) June 19, 2014: Phase III REACH (HCC 2nd line, Ramucirumab vs Placebo) did not meet primary endpoint, but subgroup analysis (alpha-fetoprotein ≥400 ng/mL, HCC) shows significant different OS between ramucirumab group and placebo.
2) Lilly did another Phase III, REACH-2 (alpha-fetoprotein ≥400 ng/mL, HCC 2nd line) met primary endpoint and ramucirumab is approved for alpha-fetoprotein ≥400 ng/mL, HCC 2nd line in May 10, 2019

2. Pembrolizumab (Keytruda): anti-PD
1) Pembrolizumab is approved for lung cancer (Oct 2, 2015), for Urothelial carcinoma (May 18, 2017), for CRC, MSI-H/dMMR (May 23, 2017), for GC, PD-L1 positive (Sep 22, 2017), etc
2) Phase III, Pembrolizumab vs Paclitaxel, GC 2nd line did not meet primary endpoint (June 4, 2018)
3) Phase III, Pembrolizumab + Chemotherapy vs Chemotherapy, GC 1st line did not meet primary endpoint (April 26, 2019)

3. Nivolumab (Opdivo): anti-PD
1) Nivolumab is approved for lung cancer (March 4, 2015) , for Renal cell cancer (Nov 23, 2015), for CRC, MSI-H/dMMR (July 11, 2018), etc
2) Phase III, Nivolumab vs Sorafenib, HCC 1st line: did not meet primary endpoint (June 24, 2019)

4. Atezolizumab (Tecentriq): anti-PD-L1
1) Phase III, IMblaze 370, Atezolizumab + cobimetinib vs Regorafenib, CRC 3rd line: did not meet primary endpoint (June 26, 2018)
2) Atezolizumab is approved for Urothelial cancer (May 18, 2016), for lung cancer (Oct 18, 2016), for Breast cancer (Mar 8, 2019), etc

5. Avelumab (Bavecio): anti-PD-L1
1) Phase III, JAVELIN Gastric 300, Avelumab vs Physician’s choice, GC 3rd line: did not meet primary endpoint (Nov 30, 2017)
2) Avelumab is approved for Merkel Cell carcinoma (Mar 23, 2017), for Urothelial carcinoma (May 9, 2017) , for Renal cell cancer (May 14, 2019)

6. Bevacizumab (Avastin): anti-VEGF
1) Bevacizumab is approved for CRC (Feb 26, 2004), for lung cancer (Oct 11, 2006), etc
2) Genentech did phase III for GC, AVAGAST study, Bevacizumab + chemotherapy vs chemotherapy did not meet primary endpoint (June 7, 2010)