FDA grants pembrolizumab accelerated approval for PMBCL

Pembrolizumab (Keytruda)
Photo courtesy of Merck
The US Food and Drug Administration (FDA) granted accelerated approval to the anti-PD-1 therapy pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL). The indication also includes patients who have relapsed after 2 or more prior lines of therapy. Pembrolizumab had received priority review for PMBCL late last year and also has orphan drug designation and breakthrough therapy designation for this indication. The FDA based its approval on data from the KEYNOTE-170 trial. [Read Article]

Ibrutinib and venetoclax combo promising in front-line CLL

Attendees at ASCO 2018 Annual Meeting
Photo by © ASCO/Zach Boyden-Holmes 2018
Ibrutinib combined with venetoclax is showing promising clinical activity in the front-line treatment of patients with chronic lymphocytic leukemia (CLL), according to investigators for the CAPTIVATE study. In the first 30 patients, 77% of treatment-naïve patients had undetected minimal residual disease (MRD) in the blood and 86% showed a similar response in the bone marrow. The overall response rate (ORR) was 100% in 11 evaluable patients. The investigators reported this initial data at the 2018 annual meeting of the American Society of Clinical Oncology. [Read Article]

Mircera approved for anemia in pediatric patients with CKD

Red blood cells
Mircera®, methoxy polyethylene glycol-epoetin beta, was approved by the US Food and Drug Administration (FDA) to treat anemia in pediatric patients who have chronic kidney disease (CKD). The drug is indicated for patients ages 5 to 17 years on hemodialysis who are switching from another erythropoiesis-stimulating agent (ESA) after their hemoglobin levels have stabilized. The FDA also approved the agent to treat adult patients with CKD-associated anemia. However, the drug is not approved to treat anemia caused by cancer chemotherapy. [Read Article]