FDA's approval letter for Genentech Inc.'s Perjeta pertuzumab outlines 13 postmarketing commitments that relate to the supply and manufacturing of the breast cancer drug. According to agency documents, Genentech submitted a timetable for completing the commitments to FDA on June 8, the same day the agency approved Perjeta.

In addition to these commitments, the Roche (SIX:ROG; OTCQX:RHHBY) unit must submit an sBLA for product containing any drug substance other than that produced in a 2010 manufacturing run