Gilead secures MSAC nod for CAR-T therapy

Pharma News: Gilead Sciences welcomes the Medical Services Advisory Committee (MSAC) recommendation for public funding of Yescarta (axicabtagene ciloleucel) as a second line treatment for relapsed or refractory (r/r) large B-cell Lymphoma (LBCL).

Yescarta (axicabtagene ciloleucel [axi-cel]) has become the first treatment in nearly three decades to demonstrate a noteworthy improvement in survival rates for this particular patient population.

With a median follow-up of four years (47.2 months), the ZUMA-7 trial found that a single treatment with Yescarta resulted in increased overall survival (p-value = 0.0168) compared to the traditional standard of care involving high-dose chemotherapy plus autologous stem cell transplant (HDT/ASCT).

The risk of death was reduced by 27.4%, equating to a remarkable 38% relative improvement in overall survival (OS) for patients with LBCL who had experienced early relapse or refractory disease within a year of completing their initial therapy.

“It puts to bed the question about how active these CAR-T treatments are and how promising they are when put up against chemotherapy,” Professor Michael Dickinson who is the Lead of Aggressive Lymphoma stream, Haematologist at the Peter MacCallum Cancer Centre and co-author of the ZUMA-7 trial.

“We will now work with urgency with the Commonwealth Government and State and Territory governments to ensure patients who can benefit from YESCARTA will receive treatment as soon as possible,” Gilead said in a statement.

The next step involves finalising a deed of agreement between the Federal Government and Gilead for 50% of the funding. Based on previous CAR-T therapies, this process could take a lengthy 18 to 30 months. Following this, negotiations with State Governments for the remaining 50% of funding will commence.

The company further added, “Gilead wish to express our sincere gratitude to the professional organisations, patient organisations, clinicians and patients themselves who took the time to support patient access.”

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