Grace is a 78-year-old female who is diagnosed with malignant neoplasm of pancreatic duct (C25.3). Grace was previously treated with surgical resection of the distal pancreatectomy, cholecystectomy, splenectomy, and low anterior resection with colorectal ostomy, gemzar, abraxane, cisplatin, opdivo, abemaciclib, galunisertib, but still experienced disease progression. Pathology demonstrates T2, N1, M1 disease with 9 out of 27 lymph nodes remarkable with metastasis to the colon. Your denial indicates that Zejula is not approved for her diagnosis. Zejula therapy is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal …show more content…
Once a product has been approved for marketing, a physician may prescribe it for uses or in treatment regimens or patient populations that are not included in approved labeling. Such “unapproved” or, more precisely, “unlabeled” uses may be appropriate and rational in certain circumstances, and may, in fact, reflect approaches to drug therapy that have been extensively reported in medical literature”. Valid new uses for drugs already on the market are often first discovered through serendipitous observations and therapeutic innovations, subsequently confirmed by well-planned and executed clinical investigations. Denying a medication for being used off-label would run contrary to the FDA’s own intent regarding the effect of its labeling, therefore, I respectfully request an exception for Zejula to be approved for Grace at this time so her therapy is no longer, unnecessarily delayed. I believe that Zejula should not be lost to those who could benefit from this treatment, and strongly feel adding Zejula will increase her chances of remission which will extend and improve her quality of life. Without this treatment, I fear her condition will continue to progress causing increased pain and suffering with a potentially fatal