Kyprolis FDA approval has everyone in the myeloma bandwagon excited. Both patients and physicians are waiting to use it. While initially there were some apprehensions as to the prescribing information and protocol to be followed…seems like the doctors have finally made up their mind.
Carfilzomib/Kyprolis developed my ONYX pharma is the new drug approved drug on the myeloma block. Kyprolis has been approved by FDA for treating refractory/relapsed myeloma patients who have had at least two prior therapies.
The Myeloma Beacon published an excellent article on how physicians are planning to use Kyprolis in myeloma patients. Many physicians have taken the survey which gives myeloma patients a good idea if they would be eligible for Kyprolis treatment. Here is a gist of the article…
Kyprolis: Which Multiple Myeloma Patients Will Physicians Treat With It?
10 Comments By Julie Shilane
Published: Aug 17, 2012 12:28 pm
Physicians in the United States are able to prescribe Kyprolis for their patients now that the drug has been approved for the treatment of multiple myeloma.
The drug’s widespread availability, however, raises the important question: For what types of myeloma patients are physicians likely to prescribe Kyprolis?
Last month, the U.S. Food and Drug Administration (FDA) approved Kyprolis (carfilzomib) for the treatment of multiple myeloma patients meeting specific criteria. The patients must have received at least two prior therapies, including Velcade (bortezomib) and an immunomodulatory agent, meaning either Revlimid (lenalidomide), thalidomide (Thalomid), or pomalidomide. The patients must also have demonstrated disease progression on or within 60 days of completing their last therapy.
Although Kyprolis has been approved by the FDA for this specific set of myeloma patients, once a drug is approved in the U.S., physicians have substantial freedom to prescribe the drug as they deem appropriate.
At the same time, Medicare, Medicaid, and private insurance companies may decide to control health care costs by restricting reimbursement of Kyprolis treatment to patients meeting the FDA criteria described above. This may particularly be the case with Kyprolis, given that it is currently the most expensive myeloma treatment available.
So, for which patients are myeloma specialists likely to prescribe Kyprolis?
To gain a better sense of what the answer to this question is likely to be, The Beacon conducted an informal survey with a wide range of myeloma specialists around the country. We asked each of them: “How do you see yourself using Kyprolis in the near future – e.g., for what kinds of patients?”
Below is what the myeloma specialists told us.
Please note that some of the comments have been edited for brevity and clarity. For consistency, comments also have been edited to refer to patent-protected drugs by their brand names.
Amrita Krishnan, City of Hope:
We would use Kyprolis for patients with relapsed myeloma. We are also going to be exploring its use in the post-transplant setting as consolidation in a clinical trial.
We have participated in several of the Kyprolis earlier trials and are very pleased about its approval as our experience with it in clinical trials has been favorable.
Ruben Niesvizky, Weill Cornell Medical College:
We are using Kyprolis upfront (first-line) in our flagship protocol ‘Car-BiRd,’ [which is a Phase 2 clinical trial that will evaluate treatment of newly diagnosed myeloma patients with Kyprolis and dexamethasone followed by treatment with clarithromycin (Biaxin), Revlimid, and dexamethasone (Decadron), and finally Revlimid alone.]
To read the entire article, click here.
- Onyx’s Multiple Myeloma Drug Kyprolis Gets FDA Approval, Now What?
- BREAKING NEWS: Kyprolis (carfilzomib) approved by the FDA
- The CureTalk Weekly Round Up: Interviews, Multiple Myeloma research, Kyprolis/Carfilzomib FDA approval, and new Malaria Drug Target
- ONYX Begins Kyprolis’ ENDEAVOR Trial In Relapsed Myeloma
- Snapshot of Kyprolis Trial Results That Led to FDA Approval of ONYX MM Drug