What is LAVERDIA-CA1 (verdinexor)?LAVERDIA-CA1 (verdinexor) is a new oral (tablet) treatment for canine lymphoma with proven efficacy for B-cell and T-cell lymphoma in both naïve and relapse cases. It is the first small-molecule selective inhibitor of nuclear export (SINE) specifically designed for veterinarian use.
How does LAVERDIA-CA1 work?LAVERDIA-CA1 is in a class of drugs known as SINE (selective inhibitor of nuclear export). They work to block the nuclear export of certain proteins which play a role in cell growth and cancer development. Blocking the export of these proteins causes tumor cells to undergo programmed cell death (apoptosis) while generally sparing healthy cells. Learn more: https://anivive.com/laverdia/moa.
What are the most common side effects of LAVERDIA-CA1?Common side effects include anorexia, diarrhea, lethargy, weight loss, and vomiting. These side effects are mild to moderate and effectively managed with medications prescribed by your veterinarians. Please see package insert for full prescribing information.
Is LAVERDIA-CA1 a cure for my dog's lymphoma?No, unfortunately, lymphoma is rarely cured, so the goal is to provide your pet with the highest quality of life for as long as possible.
Can anything cure canine lymphoma?Unfortunately, cures are rare with canine lymphoma. A bone-marrow transplant following high-dose chemotherapy and radiation has been shown to cure some canine patients with lymphoma.
What does conditional approval mean, and when will LAVERDIA-CA1 be fully approved?
LAVERDIA-CA1 is conditionally approved for the treatment for canine lymphoma by the FDA pending a full demonstration of effectiveness under application number 141-526. Conditional approval is based on the FDA’s assessment that LAVERDIA-CA1 has demonstrated that there is a reasonable expectation of efficacy for the treatment of canine lymphoma.Conditional approval means LAVERDIA-CA1 is safe and manufactured in accordance with full approval standard. Conditional approval allows Anivive to sell and market the medication for a period of five years while completing a pivotal field efficacy study. The results of the pivotal field efficacy study will be submitted to the FDA for full approval.
Is LAVERDIA-CA1 (verdinexor) being tested for efficacy against other types of cancer?Yes, investigational studies are ongoing to evaluate the efficacy and safety of verdinexor against multiple myeloma, bladder and bone cancers in dogs, and lymphoma in cats.
Can LAVERDIA-CA1 be used for cats?At this time, LAVERDIA-CA1 is not approved for use in cats.
Is LAVERDIA-CA1 available outside the US?Currently LAVERDIA-CA1 is only available in the United States. Anivive is actively working on regulatory filings in EU, UK, Japan, Australia, New Zealand, Brazil, and Canada, but does not have a timeline on possible approval nor availability in these countries.
Where can I review clinical trial data for LAVERDIA-CA1?The Anivive website contains peer-reviewed publications on the use of LAVERDIA-CA1 in canine lymphoma. Learn more: https://anivive.com/resources.