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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.
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.
FDA awards Novartis expanded approval for breast cancer therapy
The potential market for the Novartis drug Kisqali could grow markedly, now that certain early-stage breast cancer patients will be able to receive it.
FDA Expands Approval of Ribociclib to Early Breast Cancer
The FDA on Tuesday approved ribociclib (Kisqali) in combination with endocrine therapy as adjuvant treatment for early high-risk breast cancer. Already approved in the metastatic setting, the CDK4/6 inhibitor is now also indicated for patients with stages II-III disease who have hormone receptor (HR)-positive/HER2-negative tumors and a high risk for recurrence following surgery.
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 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%.
FDA expanded their approval on drug cancer drug
First News
Targeted Oncology
4d
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 Care
5d
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 ...
13d
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 Oncology
4d
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 ...
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