Revlimid (lenalidomide) – Risk of second primary malignancies in authorised indication
Revlimid (lenalidomide) is an immunomodulating agent first licensed via a European assessment procedure in 2007, subject to a number of risk minimisation measures including a pregnancy prevention plan to ensure its safe use. Structurally related to thalidomide, Revlimid is authorised for use in combination with dexamethasone for the treatment of multiple myeloma in patients who have received at least one prior therapy.
Based on an observation of a 4-fold higher incidence of second primary malignancies (SPM) in newly diagnosed multiple myeloma patients treated with lenalidomide compared to controls, a review of the benefit-risk balance of Revlimid in the authorised indication was undertaken by the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (See IMB Drug Safety Newsletters 42 and 44, available on www.imb.ie).
In the authorised indication (in previously treated multiple myeloma patients), an increase of second primary malignancies was observed (3.98 per 100 patient-years in lenalidomide treated group versus 1.38 per 100 patient-years in the control group). Non-invasive second primary malignancies comprise basal cell or squamous cell skin cancers. Most invasive second primary malignancies were solid tumour malignancies.
Based on these data, the risk of occurrence of second primary malignancies should be taken into account before initiating treatment with Revlimid. Physicians should carefully evaluate patients before and during treatment using standard cancer screening for occurrence of second primary malignancies and institute treatment as indicated.
This information was communicated via a Direct Healthcare Professional Communication (DHPC) by the manufacturing authorisation holder in agreement with the IMB and is available on www.imb.ie. *
Advice for Healthcare Professionals
- The risk of occurrence of second primary malignancies should be taken into account before initiating treatment with Revlimid.
- Physicians should carefully evaluate patients before and during treatment using standard cancer screening for the occurrence of second primary malignancies and institute treatment as indicated.
- Suspected adverse reactions, especially the occurrence of new cancers associated with the use of Revlimid should be reported to the IMB via the usual routes, see www.imb.ie for further details.
A higher incidence of second primary malignancies has been observed in patients treated with Revlimid compared to controls, within the authorised indication.
The benefit-risk balance for Revlimid remains positive within its approved patient population however prescribers should be aware of the risk of new cancers as a result of treatment with lenalidomide.
*Information on the risk of arterial and venous thromboembolic events associated with use of Revlimid was previously highlighted in a DHPC and in the 41st edition of the IMB’s DSN, and subsequently in MIMS Ireland Oncology Reference May 2011.