Good news for dog enthusiasts as USFDA grants Tanovea full approval as cancer therapy

US – The U.S Food and Drug Administration (USFDA) have granted Tanovea (rabacfosadine injection) full approval as therapy against lymphoma in dogs.

Tanovea will become the first ever conditionally approved new animal drug for the friendly canines to achieve the FDA’s full approval.

It was approved using the new animal drug approval process after initially receiving conditional approval under statutory provisions related to drugs intended for uncommon diseases or conditions in major animal species (minor uses) or for use in the minor species of animals under the FDA’s Minor Use and Minor Species (MUMS) program.

The FDA’s MUMS program is intended to make more medications legally available to veterinarians and animal owners for the treatment of minor animal species and uncommon diseases in the major animal species.

This program provides innovative ways to bring products to market for these small populations and is designed to help pharmaceutical companies overcome the financial roadblocks they face in providing limited-demand animal drugs.

Before the passage of legislation establishing the program in 2004, pharmaceutical companies would rarely attempt to bring MUMS drugs to market, because the markets were too small to generate an adequate financial return.

Friendly canines’ susceptibility to cancer

According to the National Cancer Institute, approximately 6 million new cancer diagnoses are made in dogs each year.

Since not all pets receive medical care or a definitive cancer diagnosis, this number likely would rise if every pet saw a veterinarian annually.

Taking this into consideration, the Veterinary Cancer Society estimates 1 in 4 dogs will develop cancer at some point, and almost 50% of dogs over age 10 will develop cancer.

Fortunately, half of all canine cancers are treatable if caught early enough and new treatments are continuously being researched.

The most commonly identifiable cancer within dogs are lymphoma, mast cell tumor, Osteosarcoma melanoma, mammary gland carcinomas and hemangiosarcoma.

 Lymphoma is one of the most common cancers seen in dogs, accounting for 20% of all canine cancers. Dogs are two- to five-times more likely than people to develop lymphoma, which can affect any breed at any age.

Lymphoma appears most often as swollen lymph nodes under the jaw, in front of the shoulders, or behind the knees. Occasionally, lymphoma may attack lymph nodes in the chest or abdomen, which makes breathing difficult or causes vomiting and diarrhea.

Lymphoma is generally considered treatable, depending on the type, and multidrug chemotherapy gives favorable results. Dogs who respond well to chemotherapy usually enjoy a good quality of life for the next 12 to 18 months of remission.

Mast cell tumors typically form on the skin, can vary from relatively benign to extremely aggressive, and often spread to other parts of the body. Mast cells are immune cells associated with allergies and usually are easily identified with a fine-needle aspirate.

A pet suffering from a mast cell tumor often will show signs of vomiting, diarrhea, and loss of appetite. Surgery is required to excise the entire mast cell tumor. Often, chemotherapy and radiation therapy are also indicated for severe grades of tumor.

Osteosarcoma is the most common bone cancer in dogs, occurring most frequently in large and giant breeds. Osteosarcoma routinely attacks the long bones in the limbs but can affect any bone and progresses rapidly, spreading to the lungs, lymph nodes, and other bones.

Pet owners notice swelling, lameness, or pain in the affected limb in the beginning stages. Since this disease is so aggressive and spreads extremely rapidly, the recommended course of treatment often is amputation of the affected limb followed by chemotherapy to treat metastases.

Sadly, fewer than 10% of dogs who undergo this gold-standard treatment live longer than three years.

Melanoma is one of the most common oral cancers seen in dogs and frequently is seen in breeds with dark tongues and gums.

These tumors are composed of darkly pigmented cells and can be found anywhere on the body. A malignant melanoma that develops in the oral cavity often has spread throughout the body by the time it’s first noticed and, unfortunately, is incurable.

Complete surgical removal is difficult, radiation therapy is ineffective against metastasized cells, and chemotherapy is ineffective against this type of cancer. Melanoma appears to respond to immune-based therapies and several treatments are under development.

Mammary gland carcinomas are the most common tumors in unspayed female dogs, but often are overlooked since they usually appear as small nodules around the nipple.

Unfortunately, the nodule may quickly grow into a large, painful tumor that can ulcerate and become an open wound.

Approximately 50% of these tumors are malignant, but they can be cured with surgical removal if the cancer has not metastasized. Fifty percent of malignant masses will be fatal. Spaying a dog before her first heat cycle significantly decreases the mammary cancer risk.

Hemangiosarcoma is a form of cancer that develops from cells that line the blood vessels, most commonly attacking the spleen but also the liver, heart, and skin.

Dogs with splenic tumors seldom display signs of illness until the tumor ruptures and they go into shock caused by extreme blood loss, with pale gums, sudden weakness, and labored breathing. Emergency surgery is required to stem the blood loss, followed by chemotherapy.

Sadly, this disease rarely gives warning signals until it has progressed into the later stages and treatment often is too late.

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