Allos files MAA for RSR13

ALTH filed an MAA with the EMEA for its RSR13 as an adjunct to whole brain radiation therapy (WBRT) to treat brain metastases originating from breast cancer. The company received an FDA approvable letter for RSR13 for the same indication on Wednesday. In the letter, FDA asked for data from ALTH's ongoing Phase III ENRICH trial in 360 breast cancer patients with brain metastases (see BioCentury Extra, Wednesday June 2, 2004). In May, FDA's Oncologic Drugs Advisory Committee voted 16-1 to recommend against approval of RSR13 (see BioCentury Extra, Monday May 3, 2004)..

ALTH said the MAA is based on data from its completed Phase III REACH trial in brain cancer patients. REACH missed the primary endpoint of improved survival but increased survival in a subset of patients with brain metastases originating from breast cancer. ENRICH is exclusively enrolling breast cancer patients with brain metastases. ...