Enabled access is effective immediately for Palbociclib, which is a FDA approved (humans), small molecule cyclin-dependent kinase CDK4/6 inhibitor that targets enzymes called CDK4 and CDK6. These enzymes are important in cell division. Palbociclib inhibits cell growth and suppresses DNA replication of cancer cells.
Canine cancer patients with potentially activating mutations in CDK4 or CDK6 will now have a new option for cancer therapy!
We are delivering on our mission to increase the veterinary oncology toolbox and close the knowledge gap between cancer R&D advancements. This means more therapeutic options for your patients and an improvement in DNA test actionability.
Any expansion of targeted therapy options is a cause for celebration, but we are particularly excited about Palbociclib because abnormalities in CDK are found commonly in human sarcomas, and these type of tumors are some of the most common tumors seen by veterinary oncologists. In addition, because of CDKs critical roles in sarcoma cell cycle progression and cellular transcription regulation, Pablociclib is an attractive novel anti-sarcoma drug.
Safety First: Palbociclib was vetted by our strict safety criteria and deemed relevant to canine cancer, with safety data in canines. The adverse events profile of Palbociclib, based on studies in healthy dogs found a No Observable Adverse Event Level (NOEL) of 0.2 mg/kg/day.
Palbociclib was approved by the FDA for use in humans in 2015 for patients with hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer. Palbociclib significantly improved progression-free survival in postmenopausal women when added to the therapeutic regimen. The tolerability profile was manageable in most women with neutropenia occurring most commonly and this did not have a detrimental impact on their quality of life. Palbociclib in combination with endocrine therapy is an important and valuable option for women with HR+/HER2− advanced or metastatic breast cancer.
Palbociclib can be prescribed as extra-label use by veterinarians with a valid veterinary-client-patient relationship and in a manner consistent with the provisions of the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA).
Extensive Quality Control
Prior to being added to our formulary, the drug underwent weeks of extensive testing to ensure quality, purity, strength and identity were in accordance with USP standards. Testing was performed through Wedgewood Pharmacy, one of the largest specialty compound pharmacies in the US.
In canine cancer we expect Palbociclib to be a potential option in many cancers as high levels of CDK mutations have been found in a number of most human sarcomas, and sarcomas are some of the most common cancers in dogs.
We look forward to being able to help more of your patients by offering Palbociclib and are continuing to work hard to advance our research and enable even more targeted therapies for additional mutations.