What I wish I knew about Multiple Myeloma treatments 25 years later...

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Selinexor (Xpovio) Approval-Multiple Myeloma-FDA?!

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“Selinexor (Xpovio) approval & pricing highlights what’s wrong with our system (FDA),” Mayo MM specialist Dr. Vincent Rajkumar wrote…”

I expect my thinking and comments about the Food and Drug Administration (FDA) and multiple myeloma (MM) drugs to be controversial. After all, my MM experience was…mixed.

I have been following Dr. Vincent Rajkumar for years. I consider Dr. Rajkumar to be experienced and knowledgable when it comes to the world of FDA and chemotherapy regimens.

My point is that when a MM specialist like Dr. Rajkumar makes critical comments about an FDA approved MM drug, patients and survivors should sit up and take notice.

For the record, I expect for-profit drug companies to charge what the market will bear. If a MM surivor has relaped five times and has no where to turn, he/she might very well push their oncologist to try Selinexor (Xpovia). It is the FDA’s job to police any and all sorts of abuses on the part of drug companies involving MM patients and survivors

MM patients can make poor decisions when their life is on the line. I know. I’ve been there. This is why I the FDA to needs to think like Dr. Rajkumar.

Dr. Kumar’s comments in the article below clearly explain what’s wrong with the FDA and why multiple myeloma patients and survivors must learn about and consider evidence-based therapies beyond what conventional oncology offers.

To learn more about evidence-based, non-conventional MM therapies, scroll down the page, post a question or comment and I will reply to you ASAP.

Thank you,

David Emerson

  • MM Survivor
  • MM Cancer Coach
  • Director PeopleBeatingCancer

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FDA approved a myeloma drug. Some doctors say it was the wrong decision

“In a series of tweets, a myeloma expert called the FDA accelerated approval of Karyopharm’s Xpovio “baffling” and “incorrect” and the drug’s $22,000 monthly price tag “outrageous…”

Last week, the Food and Drug Administration granted accelerated approval to Newton, Massachusetts-based Karyopharm Therapeutics’ Xpovio (selinexor) for so-called “penta-refractory” patients, meaning those who have failed on five therapies across three key drug classes. The approval was based on response rate data from the Phase IIb STORM study, as well as data from the Phase III BOSTON study that have not been disclosed publicly…

Selinexor (Xpovio) approval & pricing highlights what’s wrong with our system,” Mayo Clinic multiple myeloma specialist Dr. Vincent Rajkumar wrote in a series of tweets that several prominent myeloma experts liked or retweeted…

The approval was based on response rate data from the Phase IIb STORM study, as well as data from the Phase III BOSTON study that have not been disclosed publicly…

There’s no doubt that the penta-refractory patients represent a significant unmet need. Xpovio’s label specifies that they must have failed on two proteasome inhibitors, two immunomodulators and one CD38-targeting monoclonal antibody.

  • Velcade (bortezomib) and Ninlaro (ixazomib), Kyprolis (carfilzomib) are three marketed proteasome inhibitors.
  • Thalomid (thalidomide), Revlimid (lenalidomide) and Pomalyst (pomalidomide) are immunomodulators.
  • Darzalex (daratumumab) is the only approved anti-CD38 antibody.

But despite that unmet need, Rajkumar raised a number of questions about the data that led to the approval. He wrote that

  • the 25.3 percent response rate for Xpovio and the steroid dexamethasone observed in STORM would have been lower with Xpovio as a single agent.
  • Moreover, he continued,there were too many side effects;
  • the dosing was incorrect;
  • the study had no control group;
  • and the FDA’s Oncologic Drugs Advisory Committee (ODAC) had voted against the drug.

“An approval in the face of this is baffling,” Rajkumar wrote.

“To trade on hope and say we have to give people something – I don’t think that’s really right,” the member (of the FDA Oncologic Drugs Advisory Committee (ODAC) committee) said, adding that the agency should have waited to approve the drug until the BOSTON data were made public…

The ODAC member also cited the label’s lack of a black-box warning about toxicity as problematic. But while the label should have carried one, it is also incumbent on physicians to discuss toxicities with their patients, the member said.

Some doctors agreed with Rajkumar…

According to the ODAC briefing document, 89.4 percent of patients experienced at least one treatment-related adverse event at Grade 3-4, meaning it was deemed serious or life-threatening. There were also two deaths considered related to treatment…

Steensma called it “ridiculous to charge $22,000 per month for such a marginal drug.” Rajkumar went further. “It’s laughable to think selinexor is worth $22,000. I’d say $2,000 is too high,” he wrote in his tweet, calling the price “outrageous…”

 

 

 

 

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