US drugmaker Celgene Corp has received a recommendation from the European Medicine Agency's advisory panel for approval of its oral cancer drug Revlimid, an analogue of thalidomide.
The EMEA's Committee for Medicinal Products for Human Use has given a positive opinion to Revlimid (lenalidomide), in combination with dexamethasone, as a treatment for patients with multiple myeloma who have received at least one prior therapy. The recommendation will be forwarded to the European Commission which is expected to grant final marketing approval within two to three months and Celgene said it is initiating steps for pricing, reimbursement and distribution plans for all EU member states.
The recommendation is clearly a boost for Celgene but the EMEA is mindful of the emotions that any drug derived from thalidomide stirs and has issued a separate question and answer document that deals with the measures taken to minimise any risk of harmful effects to unborn children of patients taking the medicine.
The document notes the use of thalidomide in the late 1950s and early 1960s and its teratogenic effects. Its use during the first three months of pregnancy, mostly as a treatment for morning sickness, led to the birth of babies with malformed, short or absent limbs. During the development of Revlimid, extensive tests were carried out to find out whether lenalidomide is teratogenic in animals and although it did not affect the development of the limbs and its effect was limited compared to thalidomide, the EMEA said that “the studies were not sufficient to allow the CHMP to rule out a risk of lenalidomide also being teratogenic.”
The EMEA also noted that during the CHMP’s assessment of Revlimid, associations of thalidomide victims and of patients were consulted, and they contributed to the development of the plan put in place to manage the risks associated with the use of the drug. This involves Celgene putting a programme in place to inform doctors and pharmacists about the special measures they need to take when prescribing Revlimid, especially concerning women who may become pregnant.
These women must have a negative pregnancy test before they are prescribed Revlimid and “ideally, the test should be carried out on the same day that the medicine is prescribed and dispensed,” said the EMEA, which added that they must also agree to have a pregnancy test every four weeks during treatment, and at least once after it is stopped.
Revlimid is already approved for multiple myeloma in combination with dexamethasone in the USA and the Food and Drug Administration has backed the drug as a treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. The agency gave the green light to Celgene’s Thalomid (thalidomide) as a first-line treatment for the disease last May.
Mixed verdicts for Switzerland companies
The CHMP also gave verdicts on drugs from three Swiss firms, two positive and one less so. The committee recommended wider use of Roche's Herceptin (trastuzumab) in combination with an aromatase inhibitor in the treatment of HER2+ and ER and/or PgR positive metastatic breast cancer and extended the indication of Actelion's hypertension treatment Tracleer (bosentan) to include reduction of the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease. The CHMP also backed Centocor’s Remicade (infliximab to include the treatment of paediatric Crohn's disease in children aged 6 to 17 years who have not responded to conventional therapy.
However it maintained its negative opinion on Novartis' antifungal Mycograb (efungumab), which was intended to be used for the treatment of invasive candidiasis, in combination with amphotericin B.