Successful Launch of IBTROZI
IBTROZI received full FDA approval on June 11, and in its first full quarter as a commercial stage company, Nuvation Bio reported 204 new patients started IBTROZI, equivalent to over 15 new patient starts per week.
Strong Efficacy and Safety Profile of IBTROZI
IBTROZI demonstrated a median duration of response of 50 months in TKI-naive patients, with a 66% confirmed intracranial response rate in patients with brain metastases who were TKI pretreated.
Regulatory and Market Expansion
IBTROZI received regulatory approval in Japan and expanded access to the ROS1-positive non-small cell lung cancer market outside the U.S.
Robust Financial Performance
Nuvation Bio reported $13.1 million in total revenue in the first quarter as a commercial stage company, including $7.7 million in net product revenue from IBTROZI.
Expansion of Patient Access and Coverage
As of the end of the quarter, IBTROZI was covered by payers representing more than 80% of covered lives, up from 58% just two months prior.