By mid-afternoon, Dr. Janet Woodcock -- on behalf of the US FDA -- had weighed in with what amounts to a rather unusual pre-emptive and public warning, also by press release. The FDA warning essentially reminded oncologists that at least as to multiple myeloma, and perhaps other presently "off label" cancers (unapproved uses), especially when Keytruda is administered in combination with with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide), treating physicians should be quite circumspect.
In fact, FDA indicated that -- until more is known about the clinical trials known as Keynote 183 and 185, oncologists should generally not prescribe these combinations for multiple myeloma. [We wrote about all of this during the last major US holiday weekend, this summer -- during Fourth of July break 2017.]
This is an age old tightrope walk -- individual doctors looking for hope against hope, for patients, often essentially without other options. Quite literally the patients are ready, willing and able (after fully-informed consent) to experiment with their own lives, or what remains of them. And to be sure, that does also advance science, but such a course should never be taken routinely, or lightly.
And so, we see this age old tension play out once again: FDA properly urging caution; and treating physicians trying to help patients in any way possible. Here's a bit of the top level, less technical FDA press release, and a link to the fully technical guidance paper:
. . . .The FDA is actively examining the data from the Keytruda trials and working directly with Merck to better understand the true cause of the safety concerns. In addition, the agency is working with sponsors of other similar cancer drugs, known as PD-1/PD-L1 inhibitors, to examine other trials in which these drugs are being studied in combination with other drugs, known as immunomodulatory agents, and in which they’re being studied in combination with other classes of drugs in hematologic malignancies. The FDA will take appropriate action as warranted to ensure patients enrolled in these trials are protected and that doctors and clinical trial researchers understand the risks associated with this investigational use.
We are communicating now, given the serious nature of the safety issue, to remind doctors and patients that Keytruda is not approved for the treatment of multiple myeloma and should not be given to patients in combination with any immunomodulatory agents, including Revlimid (lenalidomide) and Pomalyst (pomalidomide), for the treatment of multiple myeloma.
We also want to ensure that patients taking Keytruda and other PD-1/PD-L1 inhibitors know that the FDA still believes the benefits of taking these drugs for their approved uses and as indicated in the labels continue to outweigh their risks. Patients taking these drugs for their approved uses should continue to take their medication as directed by their health care professional.
Today’s alert underscores the importance of why new therapies are thoroughly studied to ensure the benefits of taking them outweigh the risks to patients, and we will continue to aggressively monitor clinical trials to ensure patients are protected when safety concerns arise. . . .
Now you know. Do go out to a restful, joyous long weekend -- celebrating organized labor, in America -- I know I will.
Indeed, I will "organize" my grill to yield Mongolian, and Southern barbeque ribs, and all that the good green Earth-goddesses provide, as sides. Smile. [I will also gaze up, at Saturn -- as the evenings roll in -- thinking of twisty, copper colored lil' Cassini making her second to last full orbit, through the rings' plane. . . . we should receive a ping-- that she is okay, and functioning, around 10 PM CDT on Saturday night.] Be well, one and all -- family's in by train, tonight. Woot!
नमस्ते
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