Category: Regions

Novartis’ Kisqali the only CDK4/6 inhibitor consistent significant overall survival across entire Phase III program
June 3, 2022 Off

Novartis’ Kisqali the only CDK4/6 inhibitor consistent significant overall survival across entire Phase III program

By Dino Mustafić

Novartis today announced new overall survival (OS) and quality of life (QoL) analyses which evaluated Kisqali® (ribociclib) plus endocrine therapy for patients with hormone receptor-positive/human epidermal growth factor receptor-negative (HR+/HER2-) advanced or metastatic breast cancer. These data will be presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting,  Novartis said.

Novartis Announces Positive Phase III Results for its ESCC Drug
April 28, 2022 Off

Novartis Announces Positive Phase III Results for its ESCC Drug

By Author

Novartis has announced positive topline results from an interim analysis of the Phase III RATIONALE 306 study, which showed anti-PD-1 immune checkpoint inhibitor tislelizumab plus chemotherapy significantly improved overall survival (OS) compared to chemotherapy in patients with previously untreated unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC), regardless of PD-L1 expression.

Novo Nordisk’s NovoSeven Recommended for Approval for the Treatment of Severe Postpartum Haemorrhage by the EMA
April 22, 2022 Off

Novo Nordisk’s NovoSeven Recommended for Approval for the Treatment of Severe Postpartum Haemorrhage by the EMA

By Author

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending an extension of the Novo Nordisk’s NovoSeven (eptacog alfa) label to include treatment of women suffering from severe haemorrhage after giving birth, when medications used to induce uterine contractions and reduce bleeding (uterotonics) are insufficient to stop the bleeding.

Novartis Receives Positive CHMP Opinion for Tabrecta for Patients with METex14 Advanced NSCLC
April 22, 2022 Off

Novartis Receives Positive CHMP Opinion for Tabrecta for Patients with METex14 Advanced NSCLC

By Author

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion and recommended granting marketing authorization of Novartis’s Tabrecta (capmatinib) as a monotherapy for the treatment of adults with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to mesenchymal-epithelial-transition factor gene (MET) exon 14 (METex14) skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.