Celgene gets FDA licence extension for myeloma drug
pharmafile | February 19, 2015 | News story | Sales and Marketing | Celgene, FDA, Revlimid, lenalidomide, myeloma
The FDA has given Celgene an extended licence for its multiple myeloma drug Revlimid (lenalidomid), to include people who are newly-diagnosed with the disease.
The new indication covers Revlimid in combination with dexamethasone to include patients who have just been diagnosed with multiple myeloma. Previously this combination was only available to treat multiple myeloma patients who have received at least one prior therapy. It has been licensed in this group since June 2006.
The approval was based on safety and efficacy results from Phase III studies, including the FIRST trial, which looked at Revlimid in combination with dexamethasone compared with a combination treatment of melphalan, prednisone and thalidomide (MPT) for 18 months in around 1,600 patients.
The Revlimid combination improved median progression-free survival (PFS), the length of time a patient lives from the start of the study until the cancer either gets worse or the patient dies. PFS was significantly longer for patients treated with the Revlimid combination (25.5 months) than for those treated with MPT (21.2 months). Patients in the combination treatment group were 25% less likely to die during the study than people who had the comparison treatments.
Jacqualyn Fouse, president of haematology and oncology for Celgene, says: “At Celgene, we are very happy with the FDA’s decision, which adds information on the use of Revlimid plus dexamethasone as a first-line treatment for multiple myeloma to the prescribing information.
“Now, as part of our commitment to improving the lives of patients living with this disease, our next step is to make the benefits of this treatment regimen available to those now eligible under the expanded indication.”
Dr Kenneth Anderson, director of the Jerome Lipper multiple myeloma center in Boston, says: “The approval of Revlimid as an option for use in all patients with multiple myeloma represents a new paradigm in the management of this disease. We now have clinical evidence demonstrating that starting and keeping newly diagnosed multiple myeloma patients on REVLIMID significantly improves progression-free survival.”
In December the EMA’s Committee for Medicinal Products for Human Use (CHMP) gave Celgene a positive opinion for Revlimid as a treatment for adults with previously untreated multiple myeloma who are not eligible for a stem cell transplant.
- The FDA has given Genentech’s new drug application for cobimetinib, in combination with Roche’s Zelboraf (vemurafenib), a priority review for the treatment of people with BRAF-V600 mutation-positive advanced melanoma. The company, a division of Roche, says the FDA will make a decision on approval by August 11, 2015.
Lilian Anekwe
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