Farydak Slows Mutltiple Myeloma Progression
In February, the FDA approved a new drug called Farydak (panobinostat, which is manufactured by Novartis Pharmaceuticals) for the treatment of patients with multiple myeloma. The important thing about this drug is that it’s the first cancer drug that blocks the activity of the HDAC enzymes, which are responsible for the overproduction of the cells that cause the development of multiple myeloma.
The FDA expedited the approval of Farydak, because it believes that this new type of cancer drug can help patients with multiple myeloma who are no longer responding to their current multiple myeloma drugs. Farydak will be used for patients who have previously received at least 2 other drugs, including Velcade (bortezomib) and either Revlimid (lenalidomide), Pomalyst (pomalidomide), or Thalomid (thalidomide).
“Farydak’s approval is particularly important, because it has been shown to slow the progression of multiple myeloma,” said Dr. Richard Pazdur, Director of the FDA’s Office of Hematology and Oncology Products.
Kyprolis May Soon Be Used in Relapsed Multiple Myeloma
At the end of March, the FDA announced it would expedite the review of Amgen’s application for the use of Kyprolis (carfilzomib) in patients with relapsed multiple myeloma (myeloma that is getting worse). Kyprolis is already approved for patients with multiple myeloma who have received at least 2 previous multiple myeloma drugs.
The FDA decided to accelerate its review (which is scheduled for July) after clinical trials showed that Kyprolis doubled the time that patients with relapsed multiple myeloma did not get worse compared with patients who received Velcade.
“Achieving deep and durable responses for patients with relapsed multiple myeloma is critical towards extending the time they live without the disease progressing,” said Dr. Sean E. Harper, Executive Vice President of Research and Development at Amgen.
Revlimid for all Patients with Multiple Myeloma
Until recently, Revlimid (in combination with dexamethasone) was approved to be used in patients with multiple myeloma only after they had received at least 1 myeloma drug. In February, the FDA approved the use of Revlimid (in combination with dexamethasone) for use in all patients with multiple myeloma, including those who had just been diagnosed and had not yet received any multiple myeloma drugs.
The FDA made this decision after a clinical trial showed that patients who received Revlimid had a 25% reduction in the risk for death compared with patients who received the other drugs in the trial.
Dr. Kenneth Anderson, Director of the Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Center, said, “Now we have clinical evidence demonstrating that starting and keeping newly diagnosed multiple myeloma patients on Revlimid significantly improves progression-free survival” (that is, the duration of time before the cancer gets worse).
On the Horizon
New drugs being developed for multiple myeloma may soon become available as new treatment options for patients with multiple myeloma. These drugs include Elotuzumab from Bristol-Myers Squibb, Ixazomib from Takeda Oncology, and Daratumumab from Janssen.