The FDA recently approved a new oral therapy, Ibtrozi (taletrectinib) from Nuvation Bio Inc., indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
ROS1+ NSCLC is a rare and aggressive form of lung cancer, accounting for approximately 2% of new NSCLC cases annually. Ibtrozi, a kinase inhibitor, will compete in the limited NSCLC subset against three established therapies. Analysts suggest that Ibtrozi offers key efficacy vs. tolerability differentiators that make it a contender to break through the pack. Additionally, the approval did not include any warnings for adverse CNS side effects or a restriction of use to only the second line setting.
Nuvation announced it would launch Ibtrozi at a cost of $140,000 annually.
The company did not announce plan for distribution; however, Onco360 Specialty Pharmacy has confirmed its role as a national distribution partner for Ibtrozi.
CLICK HERE to access prescribing information
FDA Approves Ibtrozi For Adults With ROS1+ NSCLC
CLICK HERE to read the full article
