LV5FU2 or capectitabine — Competitive Intelligence Brief

LV5FU2 or capectitabine (LV5FU2 or capectitabine) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Fluoropyrimidine antimetabolite. Area: Oncology.

phase 3 Fluoropyrimidine antimetabolite Thymidylate synthase Oncology Small molecule

Target snapshot

LV5FU2 or capectitabine (LV5FU2 or capectitabine) — Federation Francophone de Cancerologie Digestive. LV5FU2 and capecitabine are fluoropyrimidine chemotherapy agents that inhibit thymidylate synthase and get incorporated into DNA/RNA to disrupt cancer cell replication.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
LV5FU2 or capectitabine TARGET	LV5FU2 or capectitabine	Federation Francophone de Cancerologie Digestive	phase 3	Fluoropyrimidine antimetabolite	Thymidylate synthase
Xeloda	capecitabine	Cheplapharm	marketed	Nucleoside Metabolic Inhibitor [EPC]	Thymidylate synthase	1998-01-01
Fudr	FLOXURIDINE		marketed	Antimetabolite [EPC]	Thymidylate synthase	1970-01-01
Folic Acid	FOLIC ACID	Pfizer	marketed	Vitamin C [EPC]	Thymidylate synthase	1946-01-01
Folferi and celecoxib	Folferi and celecoxib	Sherief Abd-Elsalam	marketed	Chemotherapy combination with COX-2 inhibitor	Topoisomerase I (irinotecan), thymidylate synthase (fluorouracil), COX-2
oxaliplatin plus capecitabine	oxaliplatin plus capecitabine	LiNing	marketed	Platinum-based chemotherapy combination	DNA (oxaliplatin); thymidylate synthase (capecitabine/5-FU)
chemotherapy of mFOLFOX6 or FOLFIRI	chemotherapy of mFOLFOX6 or FOLFIRI	Xu jianmin	marketed	Combination chemotherapy regimen	Thymidylate synthase (5-FU), DNA topoisomerase I (irinotecan), DNA (oxaliplatin)

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Fluoropyrimidine antimetabolite class)

1. Federation Francophone de Cancerologie Digestive · 2 drugs in this class
2. National Cancer Center, Korea · 2 drugs in this class
3. Hoffmann-La Roche · 1 drug in this class
4. Japan Clinical Oncology Group · 1 drug in this class
5. Jiangxi Provincial Cancer Hospital · 1 drug in this class
6. Peter MacCallum Cancer Centre, Australia · 1 drug in this class
7. Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · 1 drug in this class
8. Taiho Pharmaceutical Co., Ltd. · 1 drug in this class
9. The First Affiliated Hospital of Henan University of Science and Technology · 1 drug in this class
10. UNICANCER · 1 drug in this class