Bezuclastinib in combination with sunitinib — Competitive Intelligence Brief

Bezuclastinib in combination with sunitinib (Bezuclastinib in combination with sunitinib) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: tyrosine kinase inhibitor. Area: Oncology.

phase 2 tyrosine kinase inhibitor KIT, PDGFRα Oncology Small molecule

Target snapshot

Bezuclastinib in combination with sunitinib (Bezuclastinib in combination with sunitinib) — Sarcoma Alliance for Research through Collaboration. Bezuclastinib is a tyrosine kinase inhibitor that targets KIT and PDGFRα, and in combination with sunitinib, it is used to treat gastrointestinal stromal tumors (GIST).

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Bezuclastinib in combination with sunitinib TARGET	Bezuclastinib in combination with sunitinib	Sarcoma Alliance for Research through Collaboration	phase 2	tyrosine kinase inhibitor	KIT, PDGFRα
Inlyta	Axitinib	Pfizer	marketed	Receptor tyrosine kinase inhibitor	Vascular endothelial growth factor receptors (VEGFR)-1, VEGFR-2, VEGFR-3	2012-01-01
Sunitinib Malate (SU011248)	Sunitinib Malate (SU011248)	H. Lee Moffitt Cancer Center and Research Institute	marketed	Multi-targeted tyrosine kinase inhibitor	VEGFR, PDGFR, KIT, FLT3
Anlotinib hydrochloride capsules	Anlotinib hydrochloride capsules	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	marketed	Multi-targeted tyrosine kinase inhibitor	VEGFR, FGFR, PDGFR, c-Kit, RET
Osimertinib (Osi)	Osimertinib (Osi)	AbbVie	marketed	EGFR tyrosine kinase inhibitor (third-generation)	EGFR (Epidermal Growth Factor Receptor)
lorlatinib plus chemotherapy	lorlatinib plus chemotherapy	The First Affiliated Hospital of Guangzhou Medical University	marketed	ALK tyrosine kinase inhibitor (combination therapy)	ALK (anaplastic lymphoma kinase), ROS1
Sequential Icotinib Plus Chemotherapy	Sequential Icotinib Plus Chemotherapy	Betta Pharmaceuticals Co., Ltd.	marketed	EGFR tyrosine kinase inhibitor	EGFR (epidermal growth factor receptor)

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 (tyrosine kinase inhibitor class)

1. Centre Leon Berard · 2 drugs in this class
2. Akeso · 1 drug in this class
3. Astex Pharmaceuticals, Inc. · 1 drug in this class
4. Chengdu Zenitar Biomedical Technology Co., Ltd · 1 drug in this class
5. Jiangsu HengRui Medicine Co., Ltd. · 1 drug in this class
6. Jiangsu ShengDiYa Medicine Co., Ltd. · 1 drug in this class
7. Nanjing Leads Biolabs Co.,Ltd · 1 drug in this class
8. Ocular Therapeutix, Inc. · 1 drug in this class
9. Peking University Cancer Hospital & Institute · 1 drug in this class
10. Pfizer · 1 drug in this class