Capecitabine, Oxaliplatin, Cetuximab — Competitive Intelligence Brief

Capecitabine, Oxaliplatin, Cetuximab (Capecitabine, Oxaliplatin, Cetuximab) competitive landscape: 4 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Antineoplastic agents. Area: Oncology.

phase 2 Antineoplastic agents EGFR, thymidylate synthase Oncology Small molecule

Target snapshot

Capecitabine, Oxaliplatin, Cetuximab (Capecitabine, Oxaliplatin, Cetuximab) — Asan Medical Center. Capecitabine is a prodrug that is converted into 5-fluorouracil, which inhibits thymidylate synthase and disrupts DNA synthesis in cancer cells. Oxaliplatin is a platinum-based chemotherapy drug that works by cross-linking DNA in cancer cells, thereby inhibiting their replication. Cetuximab is a monoclonal antibody that binds to the epidermal growth factor receptor (EGFR), blocking its activation and subsequent signaling pathways that promote cancer cell growth.

Comparator set (4 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Capecitabine, Oxaliplatin, Cetuximab TARGET	Capecitabine, Oxaliplatin, Cetuximab	Asan Medical Center	phase 2	Antineoplastic agents	EGFR, thymidylate synthase
cetuximab, capecitabine	cetuximab, capecitabine	Institute of Oncology Ljubljana	phase 3	EGFR inhibitor, thymidylate synthase inhibitor	EGFR, thymidylate synthase
cytarabine and mitoxantrone	cytarabine and mitoxantrone	Pfizer	phase 3	Antineoplastic agents
S-1 plus Cisplatin	S-1 plus Cisplatin	Taiho Pharmaceutical Co., Ltd.	phase 3	Antineoplastic agents	Thymidylate synthase, DNA
cetuximab + cisplatin + vinorelbine	cetuximab + cisplatin + vinorelbine	Merck KGaA, Darmstadt, Germany	phase 3	Antineoplastic agents	EGFR

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 (Antineoplastic agents class)

1. Asan Medical Center · 1 drug in this class
2. Central European Cooperative Oncology Group · 1 drug in this class
3. Croatian Cooperative Group for Clinical Research in Oncology · 1 drug in this class
4. Eli Lilly and Company · 1 drug in this class
5. Groupe Oncologie Radiotherapie Tete et Cou · 1 drug in this class
6. Merck KGaA, Darmstadt, Germany · 1 drug in this class
7. Pfizer · 1 drug in this class
8. Taiho Pharmaceutical Co., Ltd. · 1 drug in this class