Canine T-cell lymphoma is a highly aggressive form of canine cancer, similar to human non-hodgkins lymphona and one of the most common forms of the deadly disease found in dogs. It includes approximately 75% to 80% of B-cell derived tumors, with the rest made up of T-cell or of “undetermined origin.” As a result it has been difficult to treat. Current therapeutic options for dogs involve multi-agent intravenous chemotherapy protocols with steroids such as CHOP (cyclophosphamide, hydroxydaunorubicin, vincristine [Oncovin] and prednisone), high dose steroids alone, or palliative care. Chemotherapy combinations require administration under the care of veterinary specialists (typically a board certified Veterinary Medical Oncologist), frequent blood testing and follow up visits.
While these combinations induce high response rates, more than 80% of treated dogs eventually relapse and end up surviving only 10-14 months. In addition, many owners choose not to treat their dog with lymphoma given the need to travel to see a veterinary specialist for frequent office visits not to mention the high financial burden it entails. Because of this, the need to develop alternative treatments that would allow more owners access to therapy are now considered crucial, especially since there has been little progress in managing the disease over the past 20 years until now.
However, that may soon change thanks to the Food and Drug Administration Center for Veterinary Medicine's recent approval of for Karyopharm's novel, oral Selective Inhibitor of Nuclear Transport meant to "inhibit the export of tumor suppressor proteins and leads to their accumulation in the nucleus, which re-initiates and amplifies their natural apoptotic function," explained Karyopharm's Founder, President and CSO Dr. Sharon Shacham.
"We are very pleased that FDA has found Verdinexor to be safe and have a reasonable expectation of effectiveness for treating lymphoma in client owned dogs. The diagnosis of cancer can be traumatic for dog owners and their families, " she stated.
"FDA's confirmation that the effectiveness and safety sections of Verdinexor's NADA are now complete represents an important milestone towards the availability of a novel, orally bioavailable treatment for dogs with lymphoma," added Cheryl London, D.V.M., Ph.D., Diplomate of the ACVIM (Oncology), Shackelford Professor of Veterinary Medicine at the Ohio State University College of Veterinary Medicine and Lead Investigator on the Phase 2 trial of Verdinexor that provided data to support the effectiveness part of the NADA.
Note: The application of Verdinexor to treat canine lymphoma has been designated a "minor use" in accordance with the Minor Use Minor Species (MUMS) Act. This makes the product eligible for conditional approval similar to orphan drug/accelerated approvals used for submissions of human therapeutics.