University of California, Los Angeles

The FDA approved adjuvant ribociclib (Kisqali) plus an aromatase inhibitor for hormone receptor–positive, HER2-negative stage II and III early breast cancer, based on the NATALEE trial showing improved invasive disease-free survival. The combination achieved a 3-year iDFS rate of 90.4% vs 87.1% with endocrine therapy alone, with benefits sustained over 44.2 months.

The FDA approved ribociclib plus an aromatase inhibitor as adjuvant treatment for HR-positive, HER2-negative early breast cancer at high risk of recurrence, based on NATALEE trial data showing reduced recurrence risk by 28.5%.

FDA approves adjuvant ribociclib plus AI for HR-positive, HER2-negative stage II and III early breast cancer at high risk of recurrence, including node-negative patients, based on NATALEE trial data showing improved invasive disease-free survival.

Ribociclib (Kisqali) in combination with an aromatase inhibitor received FDA approval for adjuvant treatment of HR+/HER2- stage 2 and 3 EBC at high risk of recurrence, based on the NATALEE trial data showing a 25% reduction in risk of disease recurrence and well-tolerated safety.

FDA approves Kisqali (ribociclib) with aromatase inhibitor for HR+/HER2- stage II and III EBC at high risk of recurrence, based on NATALEE trial showing 25% reduced risk of recurrence vs. endocrine therapy alone, with consistent benefit across subgroups.

FDA approves Kisqali, a ribociclib-based treatment, in combination with an aromatase inhibitor for adjuvant therapy of HR+/HER2- stage II and III early breast cancer patients at high risk of recurrence, including those with node-negative disease. The approval is supported by the Phase III NATALEE trial results, which demonstrated a 25.1% reduction in disease recurrence risk and a well-tolerated safety profile.

FDA approves Novartis' Kisqali for HR+/HER2- early breast cancer to reduce recurrence risk, based on NATALEE trial results showing a 25.1% reduction in recurrence risk with Kisqali plus endocrine therapy vs. endocrine therapy alone.

TORL-1-23, a CLDN6-targeted ADC, showed responses in heavily pretreated, CLDN6-positive advanced solid tumors, including platinum-resistant ovarian cancer, with a well-tolerated safety profile. The ORR was 26% at doses <2.4 mg/kg, 42% at 2.4 mg/kg, and 31% at 3.0 mg/kg, with a complete response rate of 4% at the highest dose. Neutropenia risk was mitigated by prophylactic pegfilgrastim, and the MTD was not yet reached.

The phase 3 ZIRCON trial reported TLX250-CDx's high accuracy in detecting ccRCC, with sensitivity of 85.5% and specificity of 87%. Telix must resubmit the BLA for TLX250-CDx after FDA concerns over sterility assurance. TLX250-CDx aims to be the first targeted PET agent for kidney cancer in the U.S.