US FDA accepts priority review to Janssen’s BLA for daratumumab

US FDA accepts priority review to Janssen’s BLA for daratumumab

The US Food and Drug Administration (FDA) has accepted priority review to Janssen Research & Development biologics license application (BLA) for daratumumab as a treatment for multiple myeloma.

It can be used to treat patients with multiple myeloma who are refractory to both a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who have received three or more prior lines of therapy, including a PI and an IMiD.

Janssen said daratumumab is an investigational human monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule.

It is believed to induce rapid tumor cell death via several immune-mediated mechanisms, including complement-dependent cytotoxicity, antibody-dependent cellular phagocytosis and antibody-dependent cellular cytotoxicity, as well as through induction of apoptosis.

The company is undertaking five phase 3 clinical studies with daratumumab in relapsed and frontline settings.

Further studies are ongoing or planned to identify its potential in other malignant and pre-malignant diseases.

The FDA designation reduces the review period to six months compared to 10 months for standard review.

If approved, daratumumab will provide a new option for double refractory, heavily pre-treated patients.

Janssen vice president of late development and global medical affairs for oncology Craig Tendler said: “Daratumumab has the potential to be the first anti-CD38 monoclonal antibody approved to treat multiple myeloma, offering these patients an important new treatment pathway.

“The FDA’s acceptance of our application for daratumumab marks an important step for people affected by multiple myeloma. We look forward to working with the FDA during this Priority Review.”

Published 07 September 2015

Source: http://processandproduction.pharmaceutical-business-review.com/

September 8, 2015 / Pharma News