Novartis’ Phase III MONALEESA-3 clinical trial of Kisqali (ribociclib) hit the key secondary endpoint, overall survival.
European Commission Approves Talzenna for Patients with Inherited BRCA-Mutated Locally Advanced or Metastatic Breast Cancer
The European Commission approved Pfizer Inc.’s Talzenna (talazoparib), an oral polypolymerase inhibitor, as monotherapy for the treatment of adult patients with germline breast cancer susceptibility gene 1/2-mutations who have human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer.
Amgen Inc. and Allergan plc announced that the U.S. FDA approved Kanjinti (trastuzumab-anns) for all approved cancer indications of the reference product Herceptin.
Novartis released data showing sharply improved overall survival rates for the breast cancer drug Kisqali, which the Swiss drugmaker hopes will help it chip away at the dominance of Pfizer’s blockbuster Ibrance.
Puma Biotechnology’s Nerlynx (neratinib), in combination with Roche’s chemotherapy drug Xeloda (capecitabine), showed a treatment advantage compared to Novartis’ Tykerb (lapatinib) and Xeloda in a Phase III breast cancer study.
An experimental breast cancer drug being developed by British drugmaker AstraZeneca and Japan’s Daiichi Sankyo’s met the main goal in a mid-stage study, bolstering the companies’ position in a highly competitive oncology market.
Pfizer announced that the U.S. Food and Drug Administration approved a supplemental New Drug Application to expand the indications for Ibrance (palbociclib) in combination with an aromatase inhibitor or fulvestrant to include men with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer.
Novartis announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion recommending an expanded indication for Kisqali (ribociclib), the CDK4/6 inhibitor with the largest body of first-line clinical trial evidence demonstrating consistent, superior and sustained efficacy compared to endocrine therapy alone.
In the wake of a Complete Response Letter issued by the U.S. FDA, Trevana Inc. is slashing one-third of the company’s workforce. Merrimack Pharmaceuticals Inc. is undertaking a corporate restructuring that included the reduction of 60 percent workforce.