Janssen/AbbVie’s Imbruvica boosted by US label update

Janssen and AbbVie’s Imbruvica (ibrutinib) has received a boost after the US regulator approved its use in first line chronic lymphocytic leukaemia/small lymphocytic lymphoma.

The US Food and Drug Administration approved a label expansion including overall survival data from the phase 3 RESONATE-2 trial in treatment naïve CLL/SLL patients 65 years or older.

The updated label also contains clinical data from the phase 3 HELIOS trial of Imbruvica’s use in combination with bendamustine and rituximab (BR) versus placebo plus BR in patients with relapsed or refractory CLL/SLL.

Imbruvica was developed in a partnership between Janssen and Pharmacyclics. But AbbVie outbid the J&J unit and paid around $21billion to buy the biotech last year, allowing it to benefit from revenues arising from the partnership.

Imbruvica is emerging as a key drug for both firms, with sales expected to break through the $1 billion barrier this year and reach $3 billion by 2020.

Still fairly recently launched, the companies will enjoy patent-protected sales until 2026 in the US and Europe, according to Druganalyst research.

The label changes could give doctors further confidence in prescribing the drug, and provide a boost to sales.

Updated data from the RESONATE-2 trial reflect a statistically significant 56% reduction in the risk of death with Imbruvica compared to chlorambucil after a median follow-up of 28.1 months. The RESONATE-2 trial served as the basis for the March 2016 FDA approval of Imbruvica as a first-line treatment for patients with CLL.

The first data from the HELIOS study on the use of Imbruvica in combination with other therapies were added to the label, highlighting the improvement in progression-free survival (PFS) and overall response rate (ORR) when using Imbruvica plus BR versus placebo plus BR in patients with relapsed/refractory CLL/SLL. Following a review of a November 2015 supplemental filing, the FDA has expanded the indication to include the use of Imbruvica for SLL patients with or without deletion of the chromosome 17p (del 17p). SLL is a slow-growing lymphoma that is similar to CLL.

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