According to Healio, the FDA recently granted Orphan Drug designation to nanatinostat and valganciclovir (“Nana-val”) for the treatment of patients with Epstein Barr virus+ diffuse large B-cell lymphoma (DLBCL). In the past, Nana-val has shown promise in treating other forms of cancer, such as plasmablastic lymphoma and T-cell lymphoma; the FDA also attributed Orphan Drug designation in these realms.
Valganciclovir is an orally-administered antiviral therapy. Alternately, nanatinostat is a HDAC inhibitor. Used together, researchers believe Nana-val will effectively and safely treat patients with EBV+ DLBCL. In preclinical studies, as well as smaller-scale studies, Nana-val showed some level of effectiveness as a therapeutic option. Moving forward, researchers may also evaluate Nana-val as a therapeutic option for patients with nasopharyngeal carcinoma.
Nana-val was recently granted Orphan Drug status. This status is given to products intended to treat, prevent, or diagnose rare diseases. According to the FDA, “rare” conditions are those affecting under 200,000 Americans. Because Nana-val received Orphan Drug status, the drug developer also gains a variety of benefits. These include tax credits, fee waivers, increased regulatory assistance, and market exclusivity (7 years worth) upon drug approval.
Diffuse Large B-Cell Lymphoma (DLBCL)
As described above, Nana-val is designed to treat patients with diffuse large B-cell lymphoma (DLBCL), the most common form of non-Hodgkin’s lymphoma. This aggressive and fast-growing cancer usually forms in lymphocytes, a type of white blood cell. Because of this, the cancer typically grows in lymph nodes, although it can affect other areas of the body. Risk factors include age (60+), having a family history of DLBCL, being immunocompromised, having an autoimmune disease, or being male. Symptoms of DLBCL include:
- Painless lymph node swelling
- Fever
- Drenching night sweats
- Unintended weight loss
- Pruritus (intense itching)
- Shortness of breath
- Abdominal or chest pain or pressure
- Diarrhea (if spread to abdomen)
- Bloody stool (if spread to abdomen)
