Joanna Sadowska, Biopharma Account Specialist at Nanolive SA, shared a post on LinkedIn:
“BIG NEWS – FDA approves Sanofi’s Sarclisa as the first anticancer therapy delivered via an on-body injector.
Sanofi has received FDA approval for subcutaneous Sarclisa Escena, making it the first cancer treatment administered through an on-body injector (OBI).
The approval covers all current multiple myeloma indications for IV Sarclisa and introduces a new way to deliver anti-CD38 therapy.
The approval was based on the Phase 3 IRAKLIA trial:
- 71.1% objective response rate.
- Non-inferior efficacy and safety.
- Significantly shorter administration time.
- 1.5% administration-related reactions vs. 25% with intravenous infusion.
This is a broader trend in pharma – companies are not only investing in new drugs but also in new delivery methods, moving away from IV injections. For example, Merck developed a subcutaneous version of Keytruda – Keytruda QLEX.”
