Nuvation Bio Gains FDA Approval for Ibtrozi to Compete with Pfizer, BMS, and Roche in Lung Cancer Market

Nearly a decade after selling Medivation to Pfizer for $14B, David Hung, M.D., is now directly competing with his former buyer and two other pharmaceutical giants—Bristol Myers Squibb (BMS) and Roche—in the non-small cell lung cancer (NSCLC) market. Hung’s latest venture, Nuvation Bio, has secured FDA approval for Ibtrozi (taletrectinib), a next-generation tyrosine kinase inhibitor (TKI) designed to treat patients with locally advanced or metastatic ROS1-positive NSCLC.
ROS1-positive NSCLC represents a relatively small, but distinct, subset of lung cancer. While not traditionally seen as a blockbuster market, the approval of Ibtrozi positions it as a new competitor to existing therapies like Pfizer’s Xalkori, Roche’s Rozlytrek, and BMS’ Augtyro. Among these, Rozlytrek and Augtyro have been the leading options as Xalkori—Pfizer’s older generation TKI—has declined in relevance due to limitations such as poor penetration of the blood-brain barrier, an important factor given the high incidence of brain metastases in ROS1-positive patients.

Hung believes Ibtrozi holds unique advantages. Unlike Augtyro, which has demonstrated strong efficacy but is associated with central nervous system (CNS) side effects like dizziness and cognitive issues, Ibtrozi does not carry any CNS-related warnings on its label. This safety profile, according to Hung, stems from Ibtrozi’s selectivity for ROS1 over TRKb, reducing off-target neurological effects. However, Ibtrozi is not without risks—it includes a label warning for QTc interval prolongation, a heart rhythm disorder not seen with Augtyro.
The drug’s efficacy was demonstrated in two single-arm studies: Trust-I (in China) and Trust-II (globally). Among TKI-naïve patients, Ibtrozi achieved response rates of 90% and 85%, respectively. In patients previously treated with TKIs, response rates were 52% in Trust-I and 62% in Trust-II. Although median duration of response wasn’t reached in TKI-naïve patients due to limited follow-up, previous pooled analyses estimated a median duration of 44.2 months and progression-free survival (PFS) of 45.6 months. These numbers are competitive with Augtyro’s reported 35.7-month PFS in TKI-naïve patients.
Ibtrozi also showed promising CNS activity, with intracranial responses in 63% of second-line patients with measurable brain metastases. Hung emphasized the importance of initiating treatment with Ibtrozi in the first-line setting, as effectiveness generally declines once disease progresses, especially in the brain.

Beyond clinical data, Hung highlighted a logistical barrier affecting ROS1 treatment adoption. Historically, patients would begin on PD-1 inhibitors and chemotherapy while awaiting genomic test results, only to remain on that regimen even after a ROS1 mutation was identified. This practice was partially influenced by outdated National Comprehensive Cancer Network (NCCN) guidelines, which were revised in January 2025 to recommend against immunotherapy in ROS1-positive NSCLC. Hung sees this change as a major tailwind for Ibtrozi’s uptake.
With around 3,000 new ROS1-positive cases diagnosed annually in the U.S., and a potential for durable, well-tolerated treatment, analysts at Jefferies believe Ibtrozi could eventually exceed $1B in annual sales. Nuvation acquired rights to Ibtrozi outside Asia through its purchase of AnHeart Therapeutics, which previously licensed the drug from Daiichi Sankyo.