Revlimid receives approval in Switzerland for treatment of multiple myeloma

Sep 5 2007

Celgene International Sarl has announced that it's oral cancer drug, Revlimid (lenalidomide) has been granted approval by the Swiss Agency for Therapeutic Products (Swissmedic) for use in combination with dexamethasone as a treatment for patients with multiple myeloma who have received at least one prior therapy.

This approval represents the first regulatory approval for Celgene in Switzerland, and Revlimid represents the first oral therapy in Switzerland for multiple myeloma patients in more than forty years. Revlimid is currently approved by the U.S. Food and Drug Administration (FDA) under 21 CFR 314.500, Acclerated Approval of New Drugs for Serious or Life-Threatening Illnesses.

Multiple myeloma is the second most commonly diagnosed blood cancer. According to the International Myeloma Foundation, there are an estimated 750,000 people with multiple myeloma worldwide. There are more than 85,000 men and women in Europe currently undergoing treatment for multiple myeloma, and 25,000 people are expected to die from this blood cancer in 2007.

Celgene International is working diligently with Swissmedic to determine next steps for pricing, reimbursement and distribution so that Revlimid is available for eligible patients in Switzerland as quickly as possible.

The Marketing Authorization Application (MAA) for Revlimid was based upon the safety and efficacy results of two large, randomized pivotal Phase III special protocol assessment trials, North American Trial MM-009 and International Trial MM-010, evaluating Revlimid plus dexamethasone in multiple myeloma patients that have received at least one prior therapy.

Celgene remains committed to the broad and global clinical development of other investigational therapies being studied in blood and solid tumor cancers.

Revlimid has obtained Orphan Drug designation in the EU, US and Australia for treatment of multiple myeloma. Revlimid is approved for use as an oral treatment in combination with dexamethasone by the European Commission, following the recommendation from the European Medicines Agency (EMEA). Revlimid is currently approved in the US by the U.S. Food and Drug Administration (FDA) for multiple myeloma patients who have received at least one prior therapy. Revlimid is also approved in the US, for treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities and subject to a restricted distribution program named RevAssist.

In the pooled multiple myeloma studies, Grade 3 and 4 hematologic toxicities were more frequent in patients treated with the combination of Revlimid (lenalidomide) and dexamethasone than in patients treated with dexamethasone alone. Patients on therapy should have their complete blood counts monitored every 2 weeks for the first 12 weeks and then monthly thereafter. Patients may require dose interruption and/or dose reduction.

In the Revlimid (lenalidomide)/dexamethasone treatment group, 151 patients (45%) underwent at least one dose interruption with or without a dose reduction of Revlimid (lenalidomide) compared to 21% in the placebo/dexamethasone treatment group. Of these patients who had one dose interruption with or without a dose reduction, 50% in the Revlimid (lenalidomide)/dexamethasone treatment group underwent at least one additional dose interruption with or without a dose reduction compared to 21% in the placebo/dexamethasone treatment group.

Other adverse events reported in multiple myeloma patients (Revlimid(R) (lenalidomide)/dexamethasone vs dexamethasone/placebo): constipation (39% vs 19%), fatigue (38% vs 37%), insomnia (32% vs 37%), muscle cramp (30% vs 21%), diarrhea (29% vs 25%), neutropenia (28% vs 5%), anemia (24% vs 17%), asthenia (23% vs 25%), pyrexia (23% vs 19%), nausea (22% vs 19%), headache (21% vs 21%), peripheral edema (21% vs 19%), dizziness (21% vs 15%), dyspnea (20% vs 15%), tremor (20% vs 7%), decreased weight (18% vs 14%), thrombocytopenia (17% vs 10%), rash (16% vs 8%), back pain (15% vs 14%), hyperglycemia (15% vs 14%), and muscle weakness (15% vs 15%).

Other adverse reactions reported in del 5q MDS patients (Revlimid (lenalidomide)): diarrhea (49%), pruritus (42%), rash (36%), fatigue (31%), constipation (24%), nausea (24%), nasopharyngitis (23%), arthralgia (22%), pyrexia (21%), back pain (21%), peripheral edema (20%), cough (20%), dizziness (20%), headache (20%), muscle cramp (18%), dyspnea (17%), and pharyngitis (16%).

Dosing is continued or modified based upon clinical and laboratory findings. Dosing modifications are recommended to manage Grade 3 or 4 neutropenia or thrombocytopenia or other Grade 3 or 4 toxicity judged to be related to lenalidomide. For other Grade 3 or 4 toxicities judged to be related to lenalidomide, hold treatment and restart at next lower dose level when toxicity has resolved to less than or equal to Grade 2.

Revlimid is an IMiDs compound, a member of a proprietary group of novel immunomodulatory agents. Revlimid and other IMiDs compounds continue to be evaluated in over 100 clinical trials in a broad range of oncological conditions, both in blood cancers and solid tumors. The IMiDs pipeline is covered by a comprehensive intellectual property estate of U.S. and foreign issued and pending patent applications including composition-of- matter and use patents.

Multiple myeloma (also known as myeloma or plasma cell myeloma) is a cancer of the blood in which malignant plasma cells are overproduced in the bone marrow. Plasma cells are white blood cells that help produce antibodies called immunoglobulins that fight infection and disease. However, most patients with multiple myeloma have cells that produce a form of immunoglobulin called paraprotein (or M protein) that does not benefit the body. In addition, the malignant plasma cells replace normal plasma cells and other white blood cells important to the immune system. Multiple myeloma cells can also attach to other tissues of the body, such as bone, and produce tumors. The cause of the disease remains unknown.