Laverdia-CA1's field trial ends, statistical analysis to begin
Most major sections of the new animal drug application for Laverdia-CA1 have been deemed complete by the FDA, bringing the drug closer to approval
Photo: Zoriana/Adobe Stock
The field study for Laverdia-CA1’s (verdinexor tablets) safety and effectiveness in dogs with lymphoma has been completed, according to Anivive, a software-driven pet health company behind the drug’s development. Laverdia-CA1, which received conditional approval from the FDA in 2021, presents a promising oral treatment option for canine lymphoma as it offers a non-invasive approach for veterinary oncology patients, according to a news release.1
For the study, 150 dogs were chosen to participate in the trial from more than 700 applicants. The study was a randomized, placebo-controlled, double-masked study that was conducted throughout 12 clinical sites in the United States. Patient treatment and data collection concluded with the closure of the final study site on December 12, 2024, according to Anivive.1
With data collection now finished, Anivive has locked the database to start statistical analysis. Results are anticipated in the coming months. The company plans to submit the Effectiveness technical section of the new animal drug application for regulatory review this summer. The FDA has already deemed all other major sections of the application complete, according to Anivive.1 The company will also be submitting for full approval of the drug in Brazil, Australia, the United Kingdom, and the European Union once the data package is finalized.
“This achievement represents a key milestone in Anivive's mission to deliver innovative cancer treatments to companion animals, such as this new first-in-class XP01 blocker,” wrote the company in a news release.1
"The completion of our critical study for LAVERDIA-CA1 marks a major milestone in bringing forward an innovative therapy for canine lymphoma,” Dylan Balsz, CEO of Anivive, said in the release.1 "We are excited to analyze the data and move closer to making an oral treatment option available for dogs living with this challenging disease."
A promising drug
In 2021, Laverdia-CA1 became the first conditionally approved oral treatment for dogs with lymphoma. The drug prevents certain proteins from leaving the nucleus of cancer cells, in turn helping these proteins control the growth of cancerous cells in dogs and prevent their spread.2 It is administered orally twice a week with at least 72 hours between doses.
When handling Laverdia-CA1 and cleaning up after a treated dog, and for 3 days post-treatment, veterinarians should wear gloves tested for use with chemotherapy drugs. Cases where gloves should be worn include handling the patient’s food and water bowls, and the patient’s feces, urine, vomit or saliva.2 Owners of dogs with lymphoma can also administer the drug at home with a veterinarian prescription and client information sheet.
According to the FDA, pregnant women, women who may become pregnant, nursing women, and children should not handle or administer Laverdia-CA1 nor touch the feces, urine, vomit or saliva of treated dogs.2
In an interview with dvm360, Craig A Clifford, DVM, MS, DACVIM (Oncology), offered insight on the novel drug. “We know for the average dog, it may hold the disease for about 3 months or so, so [the drug is] not meant to be a silver bullet—a cure-all for lymphoma,” he explained.3 “[Most] likely in the future, oncologists will be combining it with other agents in other types of protocols. But to me, knowing that 80% of lymphomas are left untreated, [the drug] gives the primary care a game changer—something else that they can utilize, other than just prednisone.”
According to Clifford, veterinary oncologists are beginning to see that Laverdia-CA1 also has a very high response rate against T cell lymphoma—a rare form of cancerous lymphoma that is challenging to treat with few drugs that treat it available. “We’re starting to see that there may be other avenues for this agent,” said Clifford.3
“Right now, I view it more as a primary care drug, and I think that’s great because to me, we’re expanding access, meaning more cases are going to get treated, and it’s an unmet need, and I think this drug checks both of those boxes,” he concluded.
References
- Anivive announces completion of Laverdia®-CA1 pivotal field study for canine lymphoma. News release. Anivive Lifesciences Inc. February 14, 2025. Accessed February 14, 2025. https://prnmedia.prnewswire.com/news-releases/anivive-announces-completion-of-laverdia-ca1-pivotal-field-study-for-canine-lymphoma-302377090.html
- FDA conditionally approves first oral tablet to treat lymphoma in dogs. News release. US Food and Drug Administration. January 11, 2021. Accessed February 14, 2025. https://www.fda.gov/news-events/press-announcements/fda-conditionally-approves-first-oral-tablet-treat-lymphoma-dogs
- Bautista-Alejandre A, Clifford C. About the novel drug for canine lymphoma. dvm360. January 6, 2025. Accessed February 14, 2025. https://www.dvm360.com/view/about-the-novel-drug-for-canine-lymphoma
