News

The FDA approved abemaciclib (Verzenio) for use in combination with fulvestrant in women with HR+/HER2- advanced breast cancer with disease progression following endocrine therapy. The CDK4/6 inhibitor has also been approved as a monotherapy for patients with HR+/HER2- breast cancer with metastatic disease who have previously received endocrine therapy and chemotherapy.

FDA approval was given to a new regimen of cabazitaxel (Jevtana) to treat men with metastatic castration-resistant prostate cancer who previously received a docetaxel-containing regimen. The approval is for 20 mg/m2 every 3 weeks in combination with prednisone. The agency approved a dose of 25 mg/m2 every 3 weeks in this patient population in 2010.

kidney cancer

Patients with untreated advanced renal cell carcinoma (RCC) lived significantly longer without disease progression when they received the multikinase inhibitor cabozantinib (Cabometyx) as initial therapy versus sunitinib (Sutent), according to results of an independent review of the randomized CABOSUN trial reported at the 2017 ESMO Congress in Madrid.

"This is a clear improvement in the outcome, with increased PFS—by about 11 months—consistent improvement in response rate, and decreases in the development of metastatic disease," said lead investigator Luis Paz-Ares, MD, chair, Medical Oncology Department, Hospital Universitario Doce de Octubre.

A new tool is helping healthcare providers determine who will benefit from palliative care starting early in the course of their treatment for cancer, according to the authors of a pilot study whose results were presented Sept. 9, during the 2017 European Society for Medical Oncology (ESMO) Congress in Madrid, Spain.

Tisagenlecleucel (Kymriah), Novartis' newly approved CAR T-cell therapy, will be put on the market with a price of $475,000 for a single infusion, an amount that is within the range anticipated by oncologists and that Novartis characterized as well below a price level that could be justified on cost.

The FDA issued a historic approval of the first Chimeric Antigen Receptor (CAR) T-Cell Therapy, authorizing the use of tisagenlecleucel (Kymriah) for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.