Health Canada Issues Revlimid Cancer Warning

Health Canada Issues Revlimid Cancer WarningHealth Canada just issued a cancer warning over Revlimid (lenalidomide). Revlimid is used in conjunction with other drugs as a treatment for multiple myeloma, as well as a blood disorder called myelodysplastic syndrome.

Celgene Inc., the maker of Revlimid, in collaboration with Health Canada, has informed Canadian healthcare providers of important information related to the safety of Revlimid capsules. In Canada, Revlimid is approved for the treatment of patients with a condition called deletion 5q myelodysplastic syndrome (del 5q MDS) who require blood transfusions for anemia (low red blood cell counts). Revlimid is also authorized when used with dexamethasone to treat patients with multiple myeloma—cancer of plasma cells—who have already received another treatment.

Revlimid safety information now includes that second cancers, such as skin cancers or other invasive solid tumors, have been reported in a small number of patients diagnosed with multiple myeloma. These cases have been reported in patients when taking, or after treatment is completed with, Revlimid. Patients are advised to speak with their healthcare professionals with any concerns about their own increased risk of having other cancers.

In Canada, Revlimid can only be prescribed to patients who are registered in and meet all of the conditions of the RevAid program, which is a controlled distribution program for Revlimid.

We recently wrote that patients treated with Revlimid may be at an increased risk of developing new cancer, which prompted the U.S. Food & Drug Administration (FDA) to announce a safety review of the drug. The FDA said it is aware of the results of controlled clinical trials that revealed a higher rate of second primary (new) malignancies, particularly acute myelogenous leukemia (AML) and B-cell lymphoma malignancies, among patients treated with Revlimid, versus those who were not. Data from evaluation of outcomes after long-term treatment also showed numerous second primary malignancies.

The FDA’s Drug Safety Communication followed news that the European Medicines Agency (EMA) began an investigation into Revlimid’s risks and benefits over possible cancer links. Both the FDA and EMA advised physicians and patients to continue to use Revlimid according to its approved use until its review is complete.

Concerns about Revlimid and secondary cancers first surfaced last year at the annual American Society of Hematology meeting when new information was presented from a study of Revlimid long-term maintenance therapy in multiple myeloma. That study reported 15 cases of secondary malignancies in Revlimid patients compared to six cases of secondary cancer in placebo patients. Another four cases of secondary cancer were reported in patients enrolled in the study but who had not yet been randomized to receive either Revlimid or placebo. The same trend showed up twice again during subsequent presentations at the conference of data from two other trials investigating long-term use of Revlimid. Across three separate studies totaling about 1,060 patients, long-term Revlimid treatment was associated with 32 secondary cancers, or 5.9%, compared to nine secondary cancers, or 1.7%, in patients treated with a placebo.

This entry was posted in Pharmaceuticals and tagged . Bookmark the permalink.


© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.