Novel therapy for newly diagnosed multiple myeloma patients TGA approved

Celgene’s novel triplet therapy for newly diagnosed multiple myeloma (NDMM) patients is now Therapeutic Goods Administration (TGA) approved. This life-threatening blood cancer claims the lives of approximately 905 Australians each year.

REVLIMID (lenalidomide) is an immunomodulating agent, and in combination with bortezomib and dexamethasone (RVd), is now indicated for the treatment of patients with previously untreated multiple myeloma.

The TGA’s positive recommendation of RVd was based on three randomised controlled clinical phase 3 studies; SWOG-S0777, PETHEMA GEM2012 and IFM 2009.

• RVd extends median overall survival (OS) to more than 7 years and progression-free survival (PFS) to more than 3.5 years – improvements of almost 2 years and 1 year, respectively, compared to patients treated with Rd.

• RVd provides an initial therapeutic option for patients with NDMM, irrespective of their transplant eligibility.

According to Professor Miles Prince, clinical haematologist and Director of Cancer Immunology and Molecular Oncology, Epworth Healthcare, Melbourne, choice of first-line therapy substantially impacts NDMM patient outcomes.

“The choice of therapy in a first-line setting is critical, given many patients fail to reach second, let alone third-line treatment. Over time, patients progressively become less responsive to therapy, and experience shorter periods of remission at, or during later lines of treatment.”

“Treatment of NDMM in Australia has seen few new entrants in the past decade. The TGA approval of a new treatment option for patients therefore represents a significant, and much anticipated advance in the management of this devastating disease.” Myeloma Australia CEO, Steve Roach, similarly welcomes the availability of new treatment options to help address the clinical unmet needs of both multiple myeloma patients and clinicians alike.

“The now available first-line triplet therapy for NDMM will better align Australia with other international healthcare systems where triplet therapies are the standard of care.”

“With an estimated 1,885 newly diagnosed cases of multiple myeloma in Australia each year, the approval of a new triplet therapy option will address an unmet clinical need, and offer a potential gain to the multiple myeloma patient community.”

Celgene has no current plans for SAS for RVd while applying for a PBS listing.

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