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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 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.
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.
Novartis’ Kisqali cleared for expanded indication by FDA
The US Food and Drug Administration (FDA) has approved Kisqali (ribociclib) 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 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 breast cancer drug Kisqali
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.
Novartis: Kisqali Reduces Recurrence Risk By 28.5% In Late-stage Early Breast Cancer Trial
Novartis Pharma AG, affiliated to Swiss drug major Novartis AG (NVS), announced Monday updated analysis from the pivotal Phase III
Breast Cancer Drug Shows Promise in Treating Childhood Brain Cancer
High-grade glioma (HGG), a type of aggressive brain cancer, accounts for the leading cause of cancer-related mortality for children and adolescents. | Cancer
Novartis CEO says FDA's extended approval of breast cancer drug is a 'landmark' for the firm
Vas Narasimhan, CEO of Novartis, comments on the progress of the firm's Kisqali metastatic breast cancer drug after the company recently received an extended approval for it from the U.S. Food and Drug Administration.
Indiatimes
2d
Kisqali wins FDA nod for breast cancer treatment: Dosage, effectiveness and side effects of the breakthrough drug
The US Food and
Drug
Administration (FDA) has approved Kisqali for early stage breast treatment. Kisqali (
ribociclib
) is a selective cyclin-dependent kinase inhibitor, a class of
drugs
that help ...
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 ...
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