A new breast cancer drug received breakthrough therapy designation from FDA, while other new treatments were approved for diabetes and dangerously low blood pressure.
Here are 3 of the top new drug approvals in late December and early January.
- Ribociclib (Kisqali, Novartis) snagged breakthrough rherapy designation for initial endocrine-based treatment of pre- or perimenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in combination with tamoxifen or an aromatase inhibitor.
“Younger women often have distinct treatment goals and needs, and it is important for oncologists to offer effective and well-studied treatment options for their specific disease,” said Samit Hirawat, MD, head of Novartis’s Oncology Global Drug Development, in a statement. “We look forward to working with FDA to make this combination therapy available to premenopausal women living with HR+/HER2- advanced breast cancer in the US as soon as possible.”
Breakthrough therapy designation is based on positive results of a phase 3 trial, which showed that Kisqali, in combination with tamoxifen or an aromatase inhibitor as initial endocrine-based therapy, significantly prolonged progression-free survival (PFS) compared to endocrine therapy alone. The median PFS was 23.8 months versus 13 months.
2. FDA approved ertugliflozin (Steglatro, Merck), an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor, as well as the fixed-dose combination ertugliflozin and sitagliptin (Steglujan, Merck), to treat type 2 diabetes.
The two drug approvals are supported by seven phase 3 studies of around 4,800 patients. Steglatro was studied as monotherapy and in combination with metformin and/or sitagliptin, as well as with insulin and a sulfonylurea, in adults with type 2 diabetes and moderate renal impairment.
“In clinical trials, treatment with Steglatro resulted in significant A1c reductions when used alone or in combination with sitagliptin,” said Juan Pablo Arias, MD, president and principal investigator of the National Research Institute in Los Angeles, in a Merck statement. “This is important, as A1c-lowering is a key component of diabetes management, and many of my adult patients may need multiple medications to help manage their condition.”
3. FDA okayed angiotensin II injection (Giapreza, La Jolla Pharmaceutical Company) for IV infusion to increase blood pressure in adults with septic or other distributive shock.
"Shock, the inability to maintain blood flow to vital tissues, can result in organ failure and death," said Norman Stockbridge, MD, PhD, director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research, in a statement from FDA. "There is a need for treatment options for critically ill hypotensive patients who do not adequately respond to available therapies."
In a clinical trial of 321 patients with shock and a critically low blood pressure, significantly more patients responded to treatment with Giapreza, compared to those treated with placebo. Giapreza effectively increased blood pressure when added to conventional treatments used to raise blood pressure.