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Colorectal cancer

Oncologyยท 10 reviewed drugsยท 26700 cited findings behind them

What the regulatory reviews cover

Regulatory review documents in this library for colorectal cancer include Opdivo, Krazati, Stivarga, Erbitux, Braftovi, Xeloda, Lonsurf, Teysuno, and Zaltrap. These drugs have been reviewed for various indications within colorectal cancer, such as metastatic disease, in combination with other therapies, or after prior treatments. The reported outcomes vary across studies, reflecting different trial designs and patient populations. For instance, Stivarga showed an Overall Survival of 10.6 months compared to 7.8 months for Placebo, while Lonsurf demonstrated a Median OS of 7.1 months. Krazati reported an Overall response rate (ORR) of 43%, and Braftovi, in combination with cetuximab and mFOLFOX6, had an Objective Response Rate (ORR) by BICR of 60.9%. It is important to note that these figures are from different studies and are not directly comparable head-to-head.

The drugs โ€” one cited result each

Opdivo

Bristol-Myers Squibb Company

Overall Response Rate (ORR): 31.7%

BRISTOL MYERS SQUIBB โ€” Opdivo FDA Summary Review (NDA/BLA 12, p.3

Krazati

Bristol-Myers Squibb Company

Overall response rate (ORR): 43%

Krazati FDA Review (NDA216340, p.18

Stivarga

Bayer Aktiengesellschaft

Overall Survival (STIVARGA): 10.6

BAYER HLTHCARE โ€” Stivarga FDA Review (NDA/BLA 203085, 2019), p.30

Erbitux

Merck B V

Objective Response Rate (ORR): 13

IMCLONE โ€” Erbitux FDA Review (NDA/BLA 125084, 2021), p.26

Braftovi

Pfizer Inc.

Objective Response Rate (ORR) by BICR: 60.9

ARRAY BIOPHARMA INC โ€” Braftovi FDA Review (NDA/BLA 210496, 2, p.75

Xeloda

Cheplapharm

1-year PFS (ITT population): 8

Cheplapharm โ€” Xeloda EMA EPAR variation assessment report (E, p.5

Lonsurf

Otsuka Holdings Co., Ltd.

Median OS: 7.1

TAIHO ONCOLOGY โ€” Lonsurf FDA Review, p.28

OPDIVO QVANTIG

Bristol-Myers Squibb Company

618 cited findings on the drug page โ†’
Teysuno

Nordic B V

OS HR for S-1 vs 5FU/Cap in mCRC: 0.93

Nordic B V โ€” Teysuno EMA EPAR variation assessment report (E, p.23

Zaltrap

Sanofi

Median overall survival (aflibercept arm): 13.5

Sanofi โ€” Zaltrap EMA EPAR public assessment report (EMEA/H/C, p.2

Different drugs were studied in different trials โ€” these figures are not head-to-head comparisons.

Explore the full evidence

Every finding behind these drugs โ€” searchable, comparable and answerable in plain language โ€” is in the Oncology research library โ†’

Lists reflect the regulatory review documents in this library, not all therapies that exist. Educational reference only โ€” not medical or investment advice.

Colorectal cancer โ€” 10 Drugs, FDA & EMA Review Findings | BioPharmaPT Oncology