FDA conditionally approves first oral canine lymphoma treatm

TIME:2021-08-03 11:48 点击次数:
Laverdia-CA1 provides an additional treatment option for dogs suffering from this devastating illness.
The US Food and Drug Administration announced today the conditional approval of Laverdia-CA1 (verdinexor tablets) to treat canine lymphoma.
The first conditionally approved oral treatment for dogs with lymphoma, Laverdia-CA1 prevents certain proteins from leaving the nucleus of cancer cells, thus allowing the proteins to control the growth and prevent the spread of cancerous cells. It is the second conditionally FDA-approved treatment for canine lymphoma. (Tanovea-CA1, an injectable, received conditional FDA approval in 2016.) Laverdia-CA1 is administered orally twice a week at home, with at least 72 hours between doses.
“Lymphoma is a devastating cancer in dogs, with few FDA-approved treatments available. This conditional approval provides a much-needed option to treat dogs with lymphoma,” says Steven M. Solomon, DVM, MPH, director of the FDA’s Center for Veterinary Medicine, in this FDA release. “We are encouraged to see drug companies bring forward applications for products to treat serious diseases, even if they affect relatively small populations.”
Conditional approval, which is an option for drugs intended for minor use in major species, provides veterinarians with access to necessary treatments while the pharmaceutical company gathers additional efficacy data. According to the FDA website, a company has up to 5 years to complete effectiveness studies to support full approval.
Laverdia-CA1’s reasonable expectation of efficacy was demonstrated in a study of 58 client-owned dogs of various breeds, weights, and genders with B- or T-cell lymphoma. All participants were followed for at least 8 months. The dogs were either newly diagnosed with lymphoma or in their first relapse after completing a single- or multi-agent chemotherapy regimen. Most of the dogs had stage III disease (generalized lymph node enlargemen


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