- Trial Phase
- Approved
- Time to Market
- Already on the market since 2012.
- Why 3/10
- KYPROLIS is an already-approved, marketed drug with no pending regulatory decision or pivotal readout in the next 12 months. It represents roughly 3% of Amgen's quarterly revenue and is a declining franchise. The next catalyst would be quarterly earnings reports showing the pace of sales erosion, which is not a binary event. Per the rubric, an approved drug with no pending binary scores 3-5; given the small contribution to Amgen's overall business, a 3 is appropriate.
Kyprolis has no upcoming binary catalysts. Watch Amgen's quarterly earnings for the trajectory of Kyprolis sales declines versus the broader multiple myeloma market growth. The key risk is accelerating share loss to newer therapies (CAR-T, bispecifics, oral drugs). For Amgen investors, Kyprolis is a legacy headwind that is more than offset by growth in Repatha, UPLIZNA, TEZSPIRE, and the emerging MariTide obesity program.
Price Chart
Executive Summary
KYPROLIS (carfilzomib) is Amgen's second-generation proteasome inhibitor approved for relapsed/refractory multiple myeloma. First approved in 2012, it has expanded to multiple combination regimens. The drug is a mature, declining franchise: Q3 2026 sales of $330M were down 8% year-over-year, driven by lower volume from intensifying competition in the multiple myeloma space (daratumumab, CAR-T therapies, bispecifics). Kyprolis represents roughly 3% of Amgen's $10.4B quarterly revenue. Patent protection extends to at least 2041, but the drug faces ongoing competitive erosion. There are no pending regulatory decisions or pivotal readouts for Kyprolis, making it a slow-bleed commercial asset within a much larger, diversified biotech portfolio.
How It Works
A proteasome inhibitor that blocks the cell's protein-recycling machinery (the proteasome). Cancer cells, especially multiple myeloma cells, rely heavily on this system to clear damaged proteins. By jamming it, Kyprolis causes toxic proteins to build up inside the cancer cell, triggering cell death. It is a second-generation drug in this class, designed to be more potent and irreversible than the first-generation drug Velcade (bortezomib).
Trial Status
KYPROLIS is fully approved by the FDA (since July 2012) for relapsed or refractory multiple myeloma. It is approved in multiple combination regimens: with dexamethasone alone, with lenalidomide + dexamethasone (KRd), with daratumumab + dexamethasone (KdD), and with isatuximab + dexamethasone (Isa-Kd). A once-weekly 70 mg/m2 dosing option was approved in 2018. Ongoing investigator-sponsored trials continue to explore combinations, including quadruplet regimens in earlier lines of therapy (e.g., the ASCENT trial in high-risk smoldering myeloma).
The Two-Sided Case
Upcoming Catalysts
- No pending regulatory decisions or pivotal readouts for Kyprolis specifically. The drug is a mature commercial asset.
Source Filing
The SecBot filing or press-release report that triggered this drug report:
Amgen PRESS-RELEASE AMGN ·Originating report