FDA OKs Adjuvant Ribociclib in Earlier Stage Breast Cancer
Unlike rival CDK 4/6 inhibitor abemaciclib, patients don't need to be lymph-node positive to receive ribociclib after surgery.
Major New Drug Approval For Preventing Recurrence In Early Stage Breast Cancer Patients: Weighing The Risks & Benefits of Kisqali
The Food and Drug Administration (FDA) has just approved the drug Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) as treatment for people with HR+/HER2- stage II and III early breast cancer (EBC) at high risk of recurrence.
Novartis Wins FDA Approval of Kisqali for Early Breast Cancer
Novartis NVS announced that the FDA has approved breast cancer drug Kisqali (ribociclib) for a broader population. The regulatory body approved Kisqali in combination with an aromatase inhibitor (AI) for the adjuvant treatment of people with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) stage II and III early breast cancer (EBC) at high risk of recurrence,
FDA Expands Approval of Ribociclib to Early Breast Cancer
The drug joins abemaciclib (Verzenio) as approved CDK4/6 inhibitors in this setting, but the broader indication for ribociclib -- which includes node-negative (N0) disease -- roughly doubles the population of early breast cancer patients eligible for adjuvant therapy with a CDK4/6 inhibitor, according to drugmaker Novartis.
FDA Approves Adjuvant Ribociclib Plus AI Therapy for HR+, HER2- Breast Cancer
The Food and Drug Administration approved ribociclib plus an aromatase inhibitor for hormone receptor (HR)–positive, HER2-negative stage II and III early breast cancer that has a high risk of recurrence.
Kisqali Approved for HR-Positive, HER2-Negative Early Breast Cancer
The FDA has approved Kisqali (ribociclib) in adults with HR-positive, HER2-negative stage II and III early breast cancer.
Novartis’ Kisqali receives US FDA approval to reduce risk of recurrence in people with HR+/HER2- early breast cancer
Novartis’ Kisqali receives US FDA approval to reduce risk of recurrence in people with HR+/HER2- early breast cancer: Basel Thursday, September 19, 2024, 13:00 Hrs [IST] Novarti
FDA approves Novartis Kisqali® to reduce risk of recurrence in people with HR+/HER2- early breast cancer
Ad hoc announcement pursuant to Art. 53 LR Broad indication in HR+/HER2- stage II and III early breast cancer (EBC) at high risk of recurrence approximately doubles population eligible for CDK4/6 inhibitor adjuvant therapy1,
FDA expands use of Kisqali to early stage breast cancer patients
Women with early stage breast cancer may now take Kisqali, a medication already approved for advanced disease.
FDA Expands Approval Of Breast Cancer Drug Kisqali To Earlier-stage Patients
Women with early-stage breast cancer may now take Kisqali, a medication already approved for advanced disease, following the U.S. Food and Drug Administration's expanded approval of the treatment, drug maker Novartis announced Tuesday.
Breast cancer drug Kisqali gets FDA approval to prevent cancer recurrence
The breast cancer drug Kisqali has received FDA approval to reduce cases of cancer recurrence. The drug was found to reduce the chances of a patient's breast cancer coming back by 25%.
Targeted Oncology2d
Ribociclib-Based Therapy Extends Survival in HR+/HER2– Breast Cancer
Targeted Oncology provides news, videos, and reviews on the rapidly evolving world of targeted therapies and immunotherapy ...
The American Journal of Managed Care4d
FDA Approves Ribociclib for Early Breast Cancer Treatment With High Recurrence Rate
The FDA approved ribociclib (Kisqali) for adjuvant treatment of high-risk, hormone receptor-positive, HER2-negative early breast cancer. The FDA approved ribociclib (Kisqali) with an aromatase ...
Relay Therapeutics Announces Positive Interim Data for RLY-2608 Demonstrating Clinically Meaningful Progression Free Survival
PFS in heavily pre-treated patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer at RP2D33% ORR across all patients ...
Targeted Oncology2d
Dual HER2 Blockade Plus Ribociclib Offers Chemo-Free Option in HR+/HER2+ Breast Cancer
Combining endocrine therapy with the dual HER2 blockade of trastuzumab and pertuzumab and the CDK4/6 inhibitor ribociclib ...