The Vanderbilt University

The FDA expanded approval of Kisqali, a CDK4/6 inhibitor, for early-stage HR-positive, HER2-negative breast cancer, reducing recurrence risk by 28.5% after four years when combined with endocrine therapy. This approval broadens access to a broader patient group compared to similar drugs like Verzenio, which is limited to high-risk cases. The cost of Kisqali over three years is approximately $300,000-$400,000, but insurance coverage is expected to increase.

The FDA expanded approval of Novartis' Kisqali for early-stage breast cancer, reducing recurrence risk by 25% after 3 years and 28.5% after 4 years. Available for HR-positive, HER2-negative cases, it broadens treatment options beyond high-risk patients. However, the cost is high, potentially $300,000-$400,000 over 3 years.

FDA expands Kisqali use for early-stage breast cancer, reducing recurrence risk by 25% after 3 years and 28.5% after 4 years in HR-positive, HER2-negative cases. Available for broader patient groups, it complements endocrine therapy, though costs up to $400,000 over 3 years.

FDA expands approval of Kisqali for early-stage HR-positive, HER2-negative breast cancer, reducing recurrence risk by 25% after 3 years and 28.5% after 4 years. Available to broader patient groups than Verzenio, it may cause fewer side effects and offers hope to younger women with rising breast cancer rates.

Research by Dag Stormoen reveals similar genetic profiles in early and late-stage urothelial tract cancer, with a small cohort of advanced-stage patients showing long survival. Genetic testing identifies targetable mutations, emphasizing early testing for targeted therapies. The long-surviving cohort is younger and has better performance status, prompting further research on overall health impact on survival.

Belzutifan showed improved PFS and ORR vs everolimus in advanced clear cell RCC but did not outperform in OS, according to the phase 3 LITESPARK-005 trial. Median PFS was 5.6 months for both drugs, with belzutifan achieving higher 12- and 24-month PFS rates. Median OS was 21.4 months with belzutifan vs 18.2 months with everolimus, with no significant difference. Belzutifan led to a higher ORR of 22.7% vs 3.5% with everolimus, and more patients remained on belzutifan treatment. No new safety signals were observed, with comparable or reduced toxicities.

Final analysis of LITESPARK-005 showed belzutifan maintained PFS and ORR benefits over everolimus in advanced clear cell RCC, with durable responses lasting over 2 years, though no OS improvement. Belzutifan, an oral HIF-2a inhibitor, led to a higher ORR (22.7%) vs everolimus (3.5%) and longer median DOR (19.3 months vs 13.7 months). Despite longer treatment duration, belzutifan exhibited comparable or reduced toxicities. No new safety signals were observed.