Q3 2021 Investor Relations Results
Participants
Company overview
Pharmaceuticals
Oncology
Financial review
Conclusion
Appendix
References
Preparing to launch our next growth drivers Scemblix® and
177Lu-PSMA-617 in H1 2022
■ First STAMP inhibitor, with potential to transform standard of care in CML
Asciminib
ScemblixⓇ1
■ Well positioned to launch in 3L CML with 80% pre-launch awareness
■ FDA and EMA 3L CML submission in June 2021
177Lu-PSMA-617
■ With FDA BTD and Fast Track designation, US approval expected by end of Q1 2022
■ 1L pivotal study initiated
■ VISION trial showed significant OS and rPFS benefit in advanced mCRPC
■ Awareness campaign on PSMA & Phenotypic Precision Medicine
Educating community centers on requirements for RLT
■ With FDA Priority Review, PDUFA expected H1 2022; EMA submission on track
■ Submitted 68 Ga-PSMA-11 kit for PET imaging to FDA, EMA submission on track
☐
Moving into earlier lines with Ph3 studies in mHSPC and mCRPC pre-taxane initiated
1. The brand name ScemblixⓇ has been provisionally approved by the FDA for the investigational product asciminib (ABL001), but the product itself has not been approved for sale in any country PSMA - Prostate-specific membrane antigen
FPFV - First patient first visit RLT Radioligand therapy rPFS-Radiographic progression-free survival STAMP - Specifically targeting the ABL myristoyl pocket
36 Investor Relations | Q3 2021 Results
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