Stage (next event)
February 28, 2021
Catalyst Info & Data Links
TITLE: Oraxol for Metastatic Breast Cancer - PDUFA
ClinicalTrial.gov NCT02594371: Ph3 Study To Determine Safety, Tolerability & Tumor Response Of Oraxol Compared To Taxol In Metastatic Breast Cancer
WHAT IS THE CATALYST EVENT?
WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?
February 28, 2021
11-05-2020 Q3 2020 Slide Deck (Slide 4)
04-09-2020 Update on Oral Paclitaxel FDA Meeting
2019: Oral paclitaxel with encequidar: The first orally administered paclitaxel shown to be superior to IV paclitaxel on confirmed response and survival with less neuropathy: A phase III clinical study in metastatic breast cancer (SABCS)
MECHANISM OF ACTION/ RATIONALE
A combination formulation composed of a capsule containing the taxane compound paclitaxel and a tablet containing the multidrug resistance (MDR) efflux pump P-glycoprotein (P-gp) inhibitor HM30181A, with potential antineoplastic activity. Upon oral administration of oraxol, the HM30181A moiety binds to and inhibits P-gp, which prevents P-gp-mediated efflux of paclitaxel, therefore enhancing its oral bioavailability.
In turn, paclitaxel binds to and stabilizes microtubules, preventing their depolymerization, which results in the inhibition of cellular motility, mitosis, and replication. Altogether, this may result in greater intracellular concentration of paclitaxel, and enhanced cytotoxicity against tumor cells, when compared to the administration of paclitaxel alone.
P-gp, encoded by the MDR-1 gene, is a member of the ATP-binding cassette (ABC) superfamily of transmembrane transporters; it prevents the intestinal uptake and intracellular accumulation of various cytotoxic agents (source).
Abraxane Abraxane label
Updated by MV
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