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July 26, 2012
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Food and Drug Administration approval of Onyx’s Kyprolis™ (carfilzomib) offers hope to myeloma patients who have run out of options when available therapies have stopped working.
FDA Approval of Kyprolis Gives Patients a Critical New Option
Kyprolis was approved by the FDA on Friday July 20th for the treatment of patients with multiple myeloma who have received at least two prior therapies, including bortezomib and an immunomodulatory agent (thalidomide or lenalidomide) and have demonstrated disease progression on or within sixty days of the completion of the last therapy.
“This is important news for patients, because Kyprolis provides a new option for patients to achieve remission and extend survival,” says Brian G.M. Durie, M.D., Chairman and Co-founder of the IMF. “Congratulations to the Onyx team.”
The IMF appreciated the opportunity to participate at the recent ODAC hearing. IMF Vice President Diane Moran and IMF Director of Support Groups Robin Tuohy, along with her husband Michael who is a myeloma patient, presented dramatic and powerful testimony demonstrating the dire need to approve new drugs such as Kyprolis.
“The committee saw first-hand what access to a new drug like Kyprolis means for patients like Michael Tuohy, who can now look forward to more years with his family, watch his children graduate from college and even start families of their own,” says Susie Novis, President and Co-founder of the IMF. She continued, “An important area of focus for the IMF is how to best support myeloma patients and their families with information, education and unparalleled expertise. The research division of the IMF, the International Myeloma Working Group, adds expertise by providing guidance as to the best uses of new drugs such as Kyprolis. Kyprolis is a powerful new addition to our ‘toolkit.’ We are just beginning to understand the full potential of this novel therapy, and as always the IMF is here to help. Kyprolis will be commercially available August 1st and the IMF, through the hotline, the Myeloma Post, the website, publications, and seminars, is ready to answer all questions.” A Kyprolis tip card and an “Understanding Kyprolis” brochure (coming soon) are available both in hard copy and on the IMF website.
READ MORE | Visit the Kyprolis Resource Page | Kyprolis Tip Card
Read About the Kyprolis Study That Led to FDA Approval
Kyprolis was approved by the FDA based on results from a recent clinical trial. Read about the results of that study, published in the latest issue of the medical journal Blood.
Our Support Group Leaders Weigh In
“I was doubly pleased to see the FDA approve Kyprolis last Friday. First of all, it adds another important treatment option in the arsenal of weapons to manage our myeloma with good quality of life. Second, living in the San Francisco Bay Area, I’ve gotten to personally know many of the folks at Proteolix, who developed Kyprolis, and then Onyx, who acquired them. They are focused on extending the lives of myeloma patients and realize the importance of not only creating a successful new drug but also providing a valuable patient assistance program to accompany it called Onyx 360.”
Co-facilitator of the SF Bay Area MM Support Group
“I am thrilled to know there is another treatment choice available for the MM community! Our Philadelphia support group has numerous members with advanced myeloma and Kyprolis offers them another avenue for hope. Although MM is still considered to be incurable, Kyprolis helps us to have increased confidence that this illness can really be seen as a chronic disease.”
Co-Leader of the Philadelphia Multiple Myeloma Networking Group
“One day after Onyx announced the FDA approval of Kyprolis (carfilzomib) for myeloma patients whose disease is progressing after two prior therapies, we had our Southeastern Virginia Multiple Myeloma Support Group meeting. Members were very excited about the approval, particularly those who meet the criteria for the new drug and were concerned about limited options for new therapies.
“They were also impressed by the rapid standup of the Onyx patient assistance service. When they called the number for Onyx Pharmaceuticals 360 (1-855-ONYX-360), a comprehensive patient and caregiver support and services program designed to help patients navigate the treatment journey, they learned about its services. These include info and assistance on reimbursement and payment support, treatment support and other support. They spoke to a dedicated Oncology Nurse Advocate who is available to assist patients, caregivers and healthcare providers regarding Kyprolis.
“One of our members shared the results of her call to them: ‘I just got off the phone with one of the nurses for Onyx…she was very helpful. She said carfilzomib is covered by Medicare Part B….she suggested that I go to their website and fill out a form which needs to be signed by the physician. This form will give Onyx the patient's authorization to contact the insurance companies involved to see what their particular insurance company will cover. In our case, it will be Medicare Part B & his supplemental policy. After the doctor signs the form, it can then be faxed, or mailed back to Onyx.’
“Bottom line - great news for myeloma patients. Thanks to all involved, including the Onyx Team, the IMF, IMF's Robin and Michael Tuohy for their testimony before the FDA committee, all the patients who participated in clinical trials, everyone else and all other organizations who helped add this weapon to the Beat Myeloma arsenal.”
Southeastern Virginia Multiple Myeloma Support Group (“SEVA”)
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Watch the ODAC Hearing Webcast
Follow the links below to watch IMF Vice President Diane Moran, IMF Director of Support Groups Robin Tuohy, and Robin’s husband and myeloma patient Michael Tuohy provide their moving testimony in support of Kyprolis approval.
They provide their testimonies in Part 3 of the webcast. The full ODAC committee hearing, where an expert panel ultimately voted 11-0 to recommend that the FDA approve Kyprolis, can be viewed at the links below. This hearing was held on June 20, 2012.
Part 1 | Part 2 | Part 3
To view this webcast, you can make sure your computer has the necessary Adobe Connect plug-ins at this website.
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