The National Comprehensive Cancer Network (NCCN) has updated its guidelines for the treatment of multiple myeloma, and the new guidelines will be interpreted by many as a vote of confidence for Revlimid maintenance therapy.
The NCCN guidelines are followed closely by physicians and by many U.S. health insurance companies, which frequently use them when making reimbursement decisions about different cancer treatments.
The guidelines are comprised of recommendations based on the results of recent clinical trials and ongoing scientific research. A panel of specialists within the myeloma field is responsible for updating the NCCN guidelines for multiple myeloma.
Previous editions of the NCCN guidelines have included Revlimid (lenalidomide) maintenance therapy as a so-called “Category 2A” recommendation. Such recommendations are considered by the NCCN to be based on “lower-level evidence.”
The newest edition of the NCCN guidelines, in contrast, lists Revlimid maintenance therapy as a “Category 1″ recommendation, meaning the NCCN believes the recommendation is supported by “high-level evidence.”
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This is important as there has been significant debate over whether the benefits of Revlimid maintenance therapy outweigh its risks.
Results from three major studies of Revlimid maintenance therapy were published in May. All three trials found that Revlimid maintenance therapy significantly delayed the progression of multiple myeloma, and one of the studies found that Revlimid maintenance therapy improved the overall survival of patients (see related Beacon news).
At the same time, all three trials revealed that patients who received Revlimid maintenance therapy were significantly more likely to experience a second cancer than those who did not receive Revlimid.
Data linking Revlimid to an increased risk of second cancers became public in 2010, and in 2011 the European Medicines Agency (EMA) as well as the U.S. Food and Drug Administration (FDA) began investigations into Revlimid’s safety.
The EMA concluded that the benefits of Revlimid, particularly improved survival, outweighed the risks. However, the agency recommended that the prescribing information for Revlimid be updated with a warning and advice to doctors on the risk of new cancers (see related Beacon news).
The FDA investigation also resulted in a warning being added to the Revlimid prescribing information stating that patients being treated with the drug have an increased risk of developing a second cancer (see related Beacon news).
The newly released NCCN guidelines contain language about Revlimid maintenance therapy similar to the warnings now included in the U.S. and European prescribing information for the drug. The language, though, is more tentative about the link between Revlimid and second cancers.
The guidelines note, “There appears to be an increased risk for secondary cancers, especially with [Revlimid] maintenance following transplant. The benefits and risk of maintenance therapy vs. secondary cancers should be discussed with patients.”
Revlimid is marketed in the U.S. and elsewhere by Celgene (NASDAQ: CELG). The company’s stock was up 2.5 percent on yesterday while the stock market as a whole was unchanged.
In addition to Revlimid, the NCCN guidelines also list thalidomide (Thalomid) and Velcade (bortezomib) as preferred maintenance therapies, with thalidomide maintenance supported by “high-level evidence” and Velcade maintenance by “lower-level evidence.”
Several additional changes were made in the latest version of the NCCN guidelines.
The guidelines now state that for Velcade-based regimens, physicians should consider using subcutaneous Velcade, instead of intravenous Velcade, for patients with pre-existing peripheral neuropathy or who are at high-risk of developing neuropathy. Peripheral neuropathy is nerve damage that results in pain, tingling, or loss of sensation in the extremities.
The recommendations for the treatment of relapsed and refractory myeloma, known as salvage therapy, were also updated.
Specifically, Velcade-thalidomide-dexamethasone (Decadron) along with Kyprolis (carfilzomib) were both added as preferred regimens supported by “lower-level evidence.” These were added to a long list of already-preferred salvage regimens, including repeating the patient’s initial therapy if it provided a remission of more than six months as well as a number of other Velcade-, Revlimid-, and chemotherapy-based regimens.
The addition of Kyprolis to the guidelines is accompanied by a note stating that Kyprolis is approved for patients who have received at least two prior therapies, including Velcade and an immunomodulatory agent, meaning either Revlimid, thalidomide, or pomalidomide. The patients must also have demonstrated disease progression on or within 60 days of completing their last therapy.
Two regimens were also added to the list of “other salvage regimens.” Those include Velcade-Zolinza (vorinostat) and Revlimid-Treanda (bendamustine)-dexamethasone, both of which were listed as supported by “lower-level evidence.”
For more information, see the NCCN guidelines for multiple myeloma (free registration required) as well as Beacon articles about previous updates to the NCCN myeloma guidelines.