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Melphalan Flufenamide- Risk of Death!?
How much damage (death) must a chemotherapy do to patients before oncology stops prescribing the drug???
Is death from chemotherapy part of the “risk/reward” thinking of conventional oncology for multiple myeloma?
I understand that multiple myeloma (MM) is an incurable blood cancer. I understand that MM patients who have relapsed several times are running out of therapy options and are dangerously close an end-stage diagnosis. And I understand that oncologists are searching for more chemotherapy regimens that may buy time for those RR/MM survivors.
I get all that.
The question then, is how additional time afforded to RR/MM patients justifies the additional pain and suffering from toxic chemotherapy?
The oncologists mentioned below have been studying melflufen for RR/MM patients. Dr. Paul Richardson is featured on OncLive talking about the side effects of melflufen.
- Dr. Richardson says that myelosuppression is challenging (risk of death???) ...
- He thinks that the possibility of treatment-induced secondary cancer is concerning...
But in June of 2021, the Food and Drug Administration (FDA) approved melflufen. Only to put a “partial hold” on it about a month later???
All those oncologists who authored the study, linked below, finding that melflufen is okay: “melflufen plus dexamethasone resulted in sustained long-term clinical benefit in patients with RRMM…”
All the oncologists receive money, perhaps a lot of money from drug companies that make chemotherapy drugs. Particularly the drug company, Oncopeptides AB, that makes melflufen.
I can’t help but wonder if money paid to the oncologists in the form of honoraria, consulting fees, research funding, advising fees, personal fees, and stock options sway or in some way bias these oncologists in favor of the highly toxic chemotherapy at the expense of multiple myeloma patients?
Do you think it is possible that money and self-interest bias’ the oncologists below to put their self interests over the pain and suffering of multiple myeloma patients?
I would like to know what you think. Scroll down the page and post a comment or a question. I will reply to you ASAP.
Thank you,
David Emerson
- Cancer Survivor
- Cancer Coach
- Director PeopleBeatingCancer
Recommended Reading:
Curcumin vs. Multiple Myeloma: The scientific evidence continues to pile up
Multiple Myeloma Therapy- Omega-3 Fatty Acids- Heart, Brain, Blood
Follow-up Trial of Myeloma Drug ‘Flopped,’ Says FDA Panel
“A federal advisory panel rejected arguments from drug manufacturer Oncopeptides AB about the merits of its multiple myeloma drug, melphalanflufenamide (Pepaxto), further dimming prospects of preserving the FDA accelerated approval granted in February 2021.
Oncopeptides AB argued that a recent post hoc analysis highlighted the drug’s benefit and aligned with the initial trial results that led to the drug’s accelerated approval; however, the majority of a US Food and Drug Administration (FDA) advisory panel disagreed.
On Thursday, the FDA’s Oncologic Drugs Advisory Committee (ODAC) considered the following question: “Given the potential detriment in overall survival (risk of death???), failure to demonstrate a progression-free survival benefit, and lack of an appropriate dose, is the benefit-risk profile of melphalan flufenamide favorable for the currently indicated patient population?”
Overall, 14 panelists voted “no” while two voted “yes.”
Melflufen plus dexamethasone in relapsed/refractory multiple myeloma: long-term survival follow-up from the Phase II study O-12-M1
Dr. Richardson on the Toxicity Profile of Melphalan Flufenamide in Multiple Myeloma
March 11, 2021
“Paul G. Richardson, MD… discusses the toxicity profile (risk o death?) of melphalan flufenamide (melflufen; Pepaxto) in relapsed/refractory multiple myeloma…
Regarding safety, myelosuppression is a challenging toxicity observed with melflufen, says Richardson…
…neutropenia appears to be well managed with growth factor support. Moreover, romiplostim (Nplate) can help control melflufen-associated thrombocytopenia, Richardson explains…
As with any cytotoxic chemotherapy, the risk of secondary myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) is concerning, says Richardson…”
Melphalan Flufenamide (Melflufen): First Approval
June 2021
“Melphalan flufenamide (melflufen, Pepaxto®) is a peptide conjugated alkylating drug developed by Oncopeptides for the treatment of multiple myeloma (MM) and amyloid light-chain amyloidosis…
Like other nitrogen mustard drugs, melphalan flufenamide exerts antitumor activity through DNA crosslinking. In February 2021, melphalan flufenamide, in combination with dexamethasone, received its first approval in the USA for the treatment of adults with relapsed or refractory (r/r) MM who have received at least four prior lines of therapy and whose disease is refractory to:
- at least one proteasome inhibitor (PI),
- one immunomodulatory agent,
- and one CD38-directed monoclonal antibody…”
FDA Has Requested a Partial Clinical Hold on All Trials With Melflufen in Following Study in R/R Myeloma
July 8, 2021
“The FDA has requested a partial clinical hold on all trials of melphalan flufenamide (melflufen; Pepaxto) following updated results of the phase 3 OCEAN study (NCT03151811), which examined the agent in combination with dexamethasone vs pomalidomide (Pomalyst)/dexamethasone in relapsed/refractory multiple myeloma, according to a press release from drug developer Oncopeptides AB.1…
Oncopeptides plans to cooperate closely with the FDA in order to perform the needed analysis to fully assess the risk/benefit profile of melflufen and get a better understanding of which patients with multiple myeloma will benefit from treatment in earlier lines of therapy within the relapsed/refractory setting…”