CER Daily Newsfeed

ICI Combos for mRCC Ranked for Overall Survival, Progression-Free Survival Benefits

(12/29, Lauren Dembeck, PhD, Renal & Urology News) reports “First-line immune checkpoint inhibitor (ICI) combinations for metastatic renal cell carcinoma (mRCC) offer modest overall survival (OS) gains, but greater progression-free survival (PFS) benefits compared with sunitinib, according to a new restricted mean survival time (RMST) analysis presented at the 2025 annual meeting of the Society of Urologic Oncology (SUO) in Phoenix, Arizona.” Full

How One US State Is Tackling the Drug Affordability Crisis

(12/30, Manasi Vaidya, Pharmaceutical Technology) reports “...If the [Maryland Prescription Drug Affordability Boards] considers a drug to be ‘unaffordable’, it can suggest a policy solution like, but not limited to UPLs. For the UPL route, [executive director Andrew York] says, the Board would consider several ways to determine the ideal price; index pricing, reference pricing, which is being considered on a federal level through the Most Favored Nation (MFN) policy, or budget-based pricing, in addition to looking at things like a drug’s value and comparative effectiveness, says York.” Full

FDA Guidance On Real-World Evidence Use Echoes 2023 Draft

(12/24, Jessica Karins, Inside Health Policy) reports “...The final guidance published last Wednesday says, ‘FDA recognizes that some data sources either provide only aggregate-level outputs or will not allow sponsors to access the participant-level data. FDA does not discourage use of these data sources, and a sponsor's inability to obtain participant-level data does not preclude FDA's evaluation.’ That language was also in the 2023 draft version of the guidance, indicating the agency may not have fundamentally changed its policy.” Subscription Required

Video: Limitations of RWD Interpretation in mCRPC

(12/24, Alicia Morgans, MD, MPH, Paul Sieber, MD, Urology Times) “Experts discuss the importance and limitations of real-world evidence in assessing cardiovascular risks associated with ARPIs, emphasizing the need for critical analysis.” View Video