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29 Jul 2019

The Therapeutic Goods Administration (TGA) has approved the triplet therapy POMALYST® (pomalidomide) in combination with bortezomib and dexamethasone (PVd), for the treatment of patients with relapsed or refractory multiple myeloma (MM) who have received at least one prior treatment regimen including lenalidomide.

The TGA’s positive opinion for PVd was based on the data from OPTIMISMM, the first prospective phase 3 trial to evaluate a POMALYST®-based triplet regimen in patients who were previously treated with lenalidomide, and who were, in the majority (70 per cent), lenalidomide refractory.

This patient population represents a growing unmet medical need for which new treatment options are necessary. Results from OPTIMISMM showed patients receiving PVd achieved progression free survival (PFS) of 11.20 months, while patients receiving bortezomib and dexamethasone (Vd) achieved PFS of 7.10 months, with the most impressive results occurring in patients who had received one prior line of therapy showing 20.73 months PFS for PVd vs 11.63 months for Vd.

There are an estimated 1,885 newly diagnosed cases annually, with median age at diagnosis of approximately 70 years.

According to Professor Andrew Spencer, Head of the Malignant Haematology and Stem Cell Transplantation Service at The Alfred Hospital and Professor of Haematology at Monash University, providing PVd to patients with relapsed myeloma represents one of the most significant advances for the Australian myeloma community over the past decade.

“The TGA approval enables our patients to gain earlier access to pomalidomide, an agent widely regarded as an effective and well-tolerated Immunomodulatory (IMiD) anti-myeloma agent,” Professor Spencer said.

“It’s exciting that for the first time in Australia, the combination of an IMiD with a proteasome inhibitor, both globally recognised standards of care, will be potentially available for patients.”

Myeloma Australia CEO Steve Roach welcomed the availability of new treatment options to help address the clinical unmet needs of MM patients in Australia.

“Myeloma accounts for approximately 15 per cent of blood cancers and 1 per cent of cancers generally. Although multiple myeloma remains incurable, survival for patients with the disease has improved thanks to the availability and advancement of treatment options,” Mr Roach said.

“The availability of PVd on the TGA represents a significant improvement for Australians living with MM. We hope that with increased accessibility to novel myeloma treatments, the disease will eventually be managed as a chronic condition rather than a fatal one.”



Published: 29 Jul 2019