Kisqali — Competitive Intelligence Brief

Kisqali (ribociclib) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: CDK4/6 inhibitor; aromatase inhibitor. Area: Oncology.

marketed CDK4/6 inhibitor; aromatase inhibitor Cyclin-dependent kinase (CDK) 4 and 6; aromatase enzyme Oncology

Target snapshot

Kisqali (ribociclib) — Novartis. Ribociclib inhibits CDK4/6 kinases to arrest G1 cell cycle phase; letrozole inhibits aromatase to reduce estrogen biosynthesis.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Kisqali TARGET	ribociclib	Novartis	marketed	CDK4/6 inhibitor; aromatase inhibitor	Cyclin-dependent kinase (CDK) 4 and 6; aromatase enzyme	2017-01-01
Ibrance	Palbociclib	Pfizer	marketed	CDK4/6 inhibitor	Cyclin-dependent kinases 4 and 6 (CDK4/6)	2015-01-01
Palbociclib	palbociclib	Pfizer Inc.	marketed	CDK4/6 inhibitor	Cyclin-dependent kinases 4 and 6 (CDK4/6)
target treatment	target treatment	Institut Bergonié	marketed	CDK4/6 inhibitor	CDK4/6
Abemaciclib + Aromatase Inhibitor	Abemaciclib + Aromatase Inhibitor	Prof. Wolfgang Janni	marketed	CDK4/6 inhibitor + Aromatase inhibitor combination	CDK4/6 + Aromatase
Abemaciclib + Fulvestrant	Abemaciclib + Fulvestrant	Prof. Wolfgang Janni	marketed	CDK4/6 inhibitor + estrogen receptor antagonist	CDK4/6 and estrogen receptor (ER)
dalpiciclib + endocrine therapy	dalpiciclib + endocrine therapy	Fujian Cancer Hospital	phase 3	CDK4/6 inhibitor	CDK4/6

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 (CDK4/6 inhibitor; aromatase inhibitor class)

1. Novartis · 1 drug in this class