FDA Approves Kyprolis
(Carfilzomib) For Relapsed And Refractory Multiple Myeloma
(From the Myeloma Beacon and the MMRF)
(From the Myeloma Beacon and the MMRF)
The United States Food and Drug
Administration (FDA) has approved carfilzomib,
which will be marketed under the brand name Kyprolis, for the treatment of people with
multiple myeloma who have received at least two prior therapies. Specifically, Kyprolis has been approved for
myeloma patients who have already been treated with at least Velcade (bortezomib) and either Revlimid (lenalidomide) or thalidomide (Thalomid) and who have also
progressed on or within 60 days of completing their last therapy.
“I am very pleased,” said Dr. Vincent
Rajkumar from the Mayo Clinic. “Carfilzomib is an excellent new drug, and this
is great news for myeloma patients.” Onyx Pharmaceuticals (NASDAQ: ONXX), which
is the company that will market Kyprolis, announced during a conference call
with analysts this afternoon that the drug will be available on the U.S. market
August 1.
Also during its conference call today, Onyx announced
the price of Kyprolis. The drug will cost $10,000 per 28-day cycle at the
recommended dose for a patient of average size.At that price and based on
FDA-approved dosing schedules, Kyprolis will be the most expensive drug
approved in the U.S. for multiple myeloma. In comparison, Velcade costs between
$4,000 to $8,000 per 28-day period, depending on the frequency of dosing, and
Revlimid costs $7,900 per 28-day period at the FDA-approved 21-out-of-28-day
dosing.
“The approval of Kyprolis is an immensely important milestone for the
multiple myeloma patient community, which continues to face significant
unmet need in terms of safe and effective treatments for advanced
disease. While we have seen tremendous progress in the past decade,
multiple myeloma remains incurable,” stated Kathy Giusti, Founder and
CEO of the MMRF and MMRC and a multiple myeloma patient. “We commend the
FDA and Onyx for their dedication to enabling patient access to
Kyprolis..."
EZ and I have been reading and hearing about carlfizomib for over a year now and we rejoice in its approval for refractory patients who have received at least two prior therapies and find them failing to contain the myeloma. Though it has been used in clinical trials, patients now have an FDA approved drug to fight advanced disease with, which is critical in their battle. While we are grateful that EZ remains in remission, we celebrate with those who need another drug to add to their arsenal.
As you can see by paragraph three above, the cost of life-saving chemotherapy for multiple myeloma is unbelievable. Krypolis will basically cost $10,000 a month. EZ has been on Velcade, and is currently taking Revlimid (about $8,000 a month). As he recently transitioned from Cobra to Medicare (on July 1st), we were shocked at what a prescription plan was going to cost us, with its premium and doughnut holes. Basically it was unaffordable due to the monthly Revlimid cost. Fortunately a series of phone calls led us to the Patient Access Network (PAN) Foundation.
Patient Access Network (PAN) Foundation
PAN is an independent non-profit organization that provides assistance to underinsured patients for their out-of-pocket expenses for life-saving medications. 90 cents of every dollar donated to PAN goes directly to our patients. Since 2004, PAN has awarded hundreds of millions of dollars in assistance to patients in need. We offer help and hope for a healthy tomorrow for the growing underinsured population struggling with increasing out-of-pocket treatment costs.
PAN, along with the grants from the Leukemia and Lymphoma Society (LLS), have made it possible for us to continue to get the medication and treatment EZ's multiple myeloma requires. If you have a blood cancer and haven't contacted these two organizations for help with your treatment costs, co-pays, and prescriptions, we urge you to do so. We are so very grateful for their help.
Have a great weekend everyone!
Have a great weekend everyone!
