Monday, April 7, 2008

Pharmion Thalidomide Receives Marketing Approval from Australian Therapeutic Goods Administration for Treatment of Newly Diagnosed Multiple Myeloma

April 7, 2008 Celgene International Sarl today announced the Australian Therapeutic Goods Administration (TGA) approved a supplemental filing granting Thalidomide Pharmion marketing approval for use in combination with melphalan and prednisone for patients with untreated multiple myeloma or ineligible for high dose chemotherapy. Additionally, Thalidomide Pharmion was granted marketing approval in combination with dexamethasone for induction therapy prior to high dose chemotherapy with autologous stem cell rescue, for the treatment of patients with untreated multiple myeloma.

This marketing approval represents the first oral cancer therapy ever registered for patients newly diagnosed with multiple myeloma in Australia.

Thalidomide Pharmion was previously approved by the TGA in 2003 as a treatment for patients with multiple myeloma after failure of standard therapies. In January 2008, the TGA granted the Company's leading oral cancer therapy REVLIMID(R) full marketing approval for use in combination with dexamethasone as a treatment for patients with multiple myeloma whose disease has progressed after one therapy.

"The TGA approval of Thalidomide Pharmion for newly diagnosed myeloma patients offers additional options in this critical disease area. When coupled with the approval of REVLIMID and dexamethasone earlier this year, we are advancing our goal of delivering vital therapies to patients in need worldwide," said Aart Brouwer, President of Celgene International. "Additionally, these approvals confirm our leadership role in blood cancer research and innovative oral therapies."

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