Merrimack: Seribantumab Gets Fast Track Designation In Patients With NSCLC

(RTTNews) - Merrimack Pharmaceuticals, Inc. (MACK) announced Wednesday that the U.S. Food and Drug Administration or FDA has granted Fast Track Designation for seribantumab, also known as MM-121, in Non-small Cell Lung Cancer.

Fast Track designation is for the development of seribantumab in patients with heregulin-positive, locally advanced or metastatic non-small cell lung cancer or NSCLC whose disease has progressed following immunotherapy.

Fast Track is a program designed by the FDA to facilitate and expedite the development and review of drugs that treat serious conditions and fill an unmet medical need.

Merrimack is conducting the SHERLOC trial, a global clinical study of seribantumab in combination with docetaxel or pemetrexed in heregulin-positive patients with NSCLC that is designed to support a Biologics License Application to the FDA. Seribantumab is Merrimack's wholly owned, fully human monoclonal antibody that targets ErbB3.