- The FDA has accepted for review Gilead Sciences Inc's Trodelvy (sacituzumab govitecan-hziy) for unresectable locally advanced or metastatic hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative breast cancer.
- The supplemental application covers patients who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
- The target action date of the Prescription Drug User Fee Act (PDUFA) is February 2023.
- The application is based on data from the registrational Phase 3 TROPiCS-02 study. In the study, Trodelvy demonstrated a 34% reduction in the risk of disease progression or death and a 21% decrease in the risk of death compared to chemo.
- The safety profile for Trodelvy in TROPiCS-02 was consistent with prior studies, with no new safety concerns identified in this population.
- Any regulatory agency has not approved Trodelvy for HR+/HER2- metastatic breast cancer.
- BMO Capital Markets upgraded Seagen Inc from Market Perform to Outperform with a price target of $178 from $177, saying the core business is undervalued.
- BMO forecasts SGEN's commercial portfolio to deliver $1.6 billion in product sales in 2022, relatively in line with consensus, and estimates sales of ~$5.3 billion in 2026, above the consensus of ~$4.9 billion.
- The main longer-term revenue driver is Padcev (enfortumab vedotin), expected to deliver sales of ~$2.1 billion in 2026 vs. a consensus of $1.9 billion.
- Padcev expansion into tumors beyond bladder cancer would represent an upside to the analyst estimates.
- Recently announced Padcev data in bladder cancer showed a 64.5% confirmed objective response rate (ORR), the primary endpoint of Cohort K.
- The analyst also notes that a permanent replacement of the CEO may provide clarity to SGEN's longer-term strategy in the wake of cooling discussions with Merck & Co Inc on a potential buyout.
