Goserelin

Experts discussed the NATALEE trial and adjuvant ribociclib in breast cancer at an FDA Special Session, emphasizing the need for further studies on dosing and benefits. The trial included 5,101 patients, with 43% completing three years of adjuvant Kisqali. The FDA approved Kisqali in 2024 for HR-positive, HER2-negative early breast cancer, with postmarketing commitments for diversity and overall survival analyses.

Kisqali, a CDK4/6 inhibitor, shows promise in treating HR-positive, HER2-negative early breast cancer, as demonstrated by the NATALEE trial. The trial involved 5,101 patients, with Kisqali given for three years alongside an aromatase inhibitor. Despite its FDA approval in 2024, follow-up studies are ongoing to assess additional benefits, dosing strategies, and overall survival. The trial highlighted the need for more diverse patient representation and ongoing research into optimal treatment durations and doses.

MEDIPEEL's export-exclusive brand, MDP+, expands its U.S. market lineup to 13 products, introducing four new items including a hyaluronic acid-infused vegan sunscreen and a peptide-enriched plumping mask. MDP+ leverages innovative formulations and on-trend packaging, achieving record sales on TikTok and aiming to align with global beauty trends.

Competition authorities are expanding their review of pharmaceutical deals, focusing on whether existing tools for identifying and remedying competition issues are sufficient. The Multilateral Pharmaceutical Merger Task Force explores new enforcement approaches, considering factors like innovation effects, conglomerate effects, and coordinated effects. Authorities in regions like the EU, US, and APAC assess theories of harm, market definitions, and legal standards, with remedies often involving divestitures to ensure market competition.

The TROPION-Breast01 phase III trial of datopotamab deruxtecan (Dato-DXd) did not achieve statistical significance in the final overall survival (OS) analysis for patients with inoperable or metastatic hormone receptor (HR)-positive, HER2-low or negative breast cancer. Despite this, the trial previously met the progression-free survival (PFS) endpoint, showing a significant improvement in PFS and patient-reported outcomes. The safety profile remained consistent with no new safety concerns. The treatment landscape's advancement with multiple antibody drug conjugates (ADCs) approved during the trial may have influenced the OS results.

TROPION-Breast01 Phase III trial of datopotamab deruxtecan did not achieve statistical significance in overall survival (OS) analysis for inoperable or metastatic HR-positive, HER2-low or negative breast cancer patients, despite meeting progression-free survival (PFS) primary endpoint. Safety profile consistent with previous analysis, with no new safety concerns. Multiple ADCs approved during trial likely affected survival results. AstraZeneca and Daiichi Sankyo continue discussions with regulatory authorities and clinical development for datopotamab deruxtecan.

Final overall survival results from TROPION-Breast01 Phase III trial of datopotamab deruxtecan (Dato-DXd) did not achieve statistical significance in HR-positive, HER2-low or negative breast cancer patients, despite positive progression-free survival results. Safety profile remained consistent with no new concerns. Subsequent treatment options likely affected survival results.

The FDA approved Kisqali with an aromatase inhibitor for postsurgical treatment of HR-positive, HER2-negative early breast cancer at high risk of recurrence. The efficacy was demonstrated in the phase 3 NATALEE trial, showing improved invasive disease-free survival. Side effects included neutropenia, liver-related issues, QT interval prolongation, and interstitial lung disease/pneumonitis.

Post-hoc analysis in DESTINY-Breast12 showed CNS ORR of 82.6% in patients without prior CNS therapy and 50.0% in those with prior therapy. Safety profiles of Enhertu were consistent with previous trials, with no new concerns. ILD/pneumonitis rates were 12.9% and 16.0% in patients without and with brain metastases, respectively, with most events being low grade.