Janssen scores PBAC recommendation for first oral, chemotherapy-free combo in blood cancer

Pharma News: Janssen secures PBAC recommendation for the first oral combination treatment, marking a chemotherapy-free milestone in blood cancer care.

Imbruvica (ibrutinib), an oral BTK inhibitor, is jointly developed and commercialised by Janssen and AbbVie. The PBAC’s recommendation is to reimburse Imbruvica (ibrutinib), in combination with Roche’s Venclexta (venetoclax), for patients with previously untreated chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).

The phase 2 Captivate clinical trial, with a 5-year follow-up, demonstrated that the combination of Imbruvica and Venclexta led to an overall progression-free survival (PFS) rate of 70% in CLL or SLL.

Urs Voegeli, Managing Director of Janssen ANZ, said “Imbruvica has helped transform the standard of care for adults living with relapsed CLL/SLL, and we are determined to expand its access to improve outcomes for more patients in Australia. The PBAC’s recommendation is a promising step forward. We are committed to supporting the needs and preferences of CLL/SLL patients and their treating clinicians.”

Although real-world data from Australia and New Zealand demonstrated significant clinical benefits of Imbruvica for patients with relapsed or refractory CLL or SLL, the global market has seen Imbruvica face competition from BeiGene’s oral Brukinsa (zanubrutinib) in this patient cohort.

In a head-to-head trial, Brukinsa showed superiority in efficacy, in addition to a safety edge evidenced by lower rates of treatment discontinuation and fewer cardiac events.

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