Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Pharmaceutical firm Celgene's oral cancer drug Revlimid has received recommendation for approval from the Australian Drug Evaluation Committee for use in combination with dexamethasone as a treatment for patients with multiple myeloma whose disease has progressed after one therapy.
Subscribe to our email newsletter
Australian Drug Evaluation Committee’s (ADEC) recommendation for approval will be forwarded to the Therapeutic Goods Administration (TGA) for ratification. The TGA generally supports the recommendations of the ADEC and grants marketing approval after the final prescribing information is negotiated and certificates of registration are issued. This process can take anywhere from two to six weeks.
Aart Brouwer, president of Celgene International, said: “The ADEC recommendation is an especially important and positive milestone for Celgene. We are fully committed to provide Revlimid to patients in need throughout Australia. We’re optimistic that Revlimid will have broad support based on its clinical benefits to patients. Upon approval we will be initiating the next steps for pricing, reimbursement and distribution.”