We are international
Donate
TEXT SIZE   


FDA Approves Aredia For The Treatment Of Myeloma Bone Disease
07.25.95
AT ITS JULY 24, 1995 MEETING, THE FDA'S ONCOLOGIC DRUG ADVISORY COMMITTEE UNANIMOUSLY AGREED THAT CIBA/CHIRON AREDIA® (PAMIDRONATE) IS SAFE AND EFFECTIVE FOR PREVENTION OF SKELETAL MORBIDITY IN MULTIPLE MYELOMA

Ciba/Chiron's Aredia® is a bisphosphonate which is given by IV infusion. It has been proven to reduce the frequency of "Skeletal Related Events" ([SREs] i.e., pathologic fractures, radiation therapy, surgery to bone and spinal cord compression) in myeloma patients. Aredia® is thought to have this effect because it inhibits the process of bone resorption (see diagram below).

The unanimous approval by the FDA's Oncologic Drugs Advisory Committee is an important step on the road to formal FDA approval of Aredia® for use in multiple myeloma. The drug has been available for some time and is also used for treatment of other conditions, such as hypercalcemia and osteoporosis. Many myeloma patients have been treated with Aredia® as a preventative measure as part of clinical trials and independently, although the lack of FDA approval for this usage of the drug has been an issue with some insurance plans.

Ciba presented nine month follow-up data from a double-blind placebo-controlled study patients over 18 years old with Stage III myeloma and at least one lytic bone lesion. Subjects were randomized, with 141 patients on placebo and 152 on Aredia® 90mg infused over four hours once a month for nine months.

Overall, 24% of those receiving Aredia® had SREs within the nine months, versus 41% of the placebo patients. Patients were stratified by type of myeloma therapy being administered. Of those for whom Aredia® was a second-line therapy (given in addition to first-line treatment (typically a chemotherapy protocol based on a single cytotoxic agent, such as melphalan), 29% had SREs, compared with 54% in the placebo group. Of those for whom Aredia® was first-line therapy, 22% had SREs, compared with 33% in the placebo group.

While there were no statistically significant differences in survival, there were clear advantages for the Aredia® group in radiographic bone response, pain relief, analgesic use and quality of life.

The committee was "most concerned" that Ciba investigate optimal duration of Aredia® therapy, explore the timing of initial Aredia® therapy in the course of myeloma, and further define optimal dose and schedule of pamidronate.
Aredia® therapy remains one of the more promising supportive care approaches and promises to help reduce bone destruction, on of the most serious impacts of myeloma on patients' quality of life.



For further discussion on this subject, please consult the following references:
Chiron Therapeutics 9/5/95 News Release
"Myeloma Bone Disease" by Prof. Gregory R. Mundy Myeloma Today, Number 10, Summer 1995

Pamidronate Disodium Reduces The Occurrence of Skeletal Related Events (SRE) In Advanced Multiple Myeloma (MM) Proceedings of the American Society of Hematology (ASH) Blood, Volume 84, Number 10, Supplement 1, November 15, 1994 (p386A)

"Myeloma is also a Bone Disease" by Francesca Morosani Thompson, MD Myeloma Today, Number 7.

"Bone Problems in Multiple Myeloma" by Dr. Brian G.M. Durie Myeloma Today, Number 6.


 related articles