Just a heads up for everyone ... Takeda Pharmaceuticals today announced that it has submitted a new drug application for ixazomib (MLN9708) to the U.S. Food and Drug Administration (FDA). The application requests that the FDA approve ixazomib as a new treatment for relapsed or refractory multiple myeloma.
You can read the full press release from Takeda about the submission here at The Beacon:
"Takeda Submits New Drug Application For Ixazomib For Patients With Relapsed / Refractory Multiple Myeloma" (July 14, 2014 - 1:00 p.m. Eastern)
Ixazomib is in the same class of drugs, known as proteasome inhibitors, as Velcade (bortezomib) and Kyprolis (carfilzomib). Unlike those other two drugs, however, ixazomib is an orally administered drug, which makes it more amenable for use in longer-term therapy, such as maintenance therapy.
You can find earlier Beacon news articles about ixazomib at the ixazomib topic page here at The Beacon. There also have been a few discussions here at The Beacon about ixazomib; you can find them many of them at this link.
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Re: Ixazomib (MLN9708) submitted to FDA for review
From the linked press release from Takeda Pharmaceuticals:
The oral pill for a proteasome inhibitor could be really helpful in long-term treatments. Good to know that the clinical trials have Phase 3 results and that the company is applying for approval to the FDA. It had an 'Orphan Drug' designation too. In the press release is also the best short description of multiple myeloma that I have read yet.
“Continuous treatment is emerging as a standard of care in multiple myeloma with demonstrable improvement in long-term outcomes,” commented Paul Richardson, M.D., Clinical Program Leader and Director of Clinical Research, Jerome Lipper Multiple Myeloma Center, Institute Physician at Dana-Farber Cancer Institute. “Proteasome inhibition has become an essential component of treatment, but there are logistical challenges for patients with both intravenous and subcutaneous approaches, and especially in the absence of an effective oral option. If approved, ixazomib, with the convenience of once-a-week oral administration as well as promising efficacy, should provide a very meaningful advance for our patients.”
The oral pill for a proteasome inhibitor could be really helpful in long-term treatments. Good to know that the clinical trials have Phase 3 results and that the company is applying for approval to the FDA. It had an 'Orphan Drug' designation too. In the press release is also the best short description of multiple myeloma that I have read yet.
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Nancy Shamanna - Name: Nancy Shamanna
- Who do you know with myeloma?: Self and others too
- When were you/they diagnosed?: July 2009
Re: Ixazomib (MLN9708) submitted to FDA for review
Hi Nancy,
I, too, noticed the quote from Dr. Richardson about continuous therapy in the press release. My cynical side thinks it worth mentioning that Takeda (Millennium) never really talked much about the benefits of continuous therapy when the only drug the company had was Velcade, which hasn't always been that easy to use for extended periods of time. Now that Takeda has an oral drug which might (and I emphasize "might") have less issues with peripheral neuropathy than Velcade, the company all of a sudden is pushing the idea of continuous therapy.
It's also worth noting that most of the data from Phase 3 trials that support continuous therapy come from trials involving Revlimid -- not Velcade or ixazomib. Also, as we know just from the discussions here in the forum, there is debate about just how much the data out there really support continuous therapy.
I, too, noticed the quote from Dr. Richardson about continuous therapy in the press release. My cynical side thinks it worth mentioning that Takeda (Millennium) never really talked much about the benefits of continuous therapy when the only drug the company had was Velcade, which hasn't always been that easy to use for extended periods of time. Now that Takeda has an oral drug which might (and I emphasize "might") have less issues with peripheral neuropathy than Velcade, the company all of a sudden is pushing the idea of continuous therapy.
It's also worth noting that most of the data from Phase 3 trials that support continuous therapy come from trials involving Revlimid -- not Velcade or ixazomib. Also, as we know just from the discussions here in the forum, there is debate about just how much the data out there really support continuous therapy.
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