Janssen Biotech has received approval from the US Food and Drug Administration (FDA) to use its Imbruvica (ibrutinib) capsules for treatment of patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.
Imbruvica is being jointly developed and commercialised by Janssen and Pharmacyclics. It is the first once-daily, single-agent, oral Bruton’s tyrosine kinase (BTK) inhibitor for patients with CLL, a slow-growing blood cancer of white blood cells called lymphocytes, most commonly B cells.
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The drug was previously approved by FDA in November 2013 to treat mantle cell lymphoma (MCL) patients who have received at least one prior therapy.
Imbruvica works by blocking BTK, a major signaling molecule of the B-cell receptor signalling complex that plays a major role in the survival of malignant B cells.
FDA’s Center for Drug Evaluation and Research director of the Office of Hematology and Oncology Products Richard Pazdur said: "The FDA completed its review of Imbruvica’s new indication under the agency’s accelerated approval process, which played a vital role in rapidly making this new therapy available to those who need it most."
Non-clinical studies have demonstrated that blocking BTK inhibits the enzyme needed by the cancer to multiply and spread.
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By GlobalDataBoth CLL and MCL were granted priority review based on an overall response rate (ORR) and approved under the FDA’s accelerated approval programme.
Janssen vice-president of late-stage development and global medical affairs for oncology Craig Tendler said: "The speed at which we were able to bring IMBRUVICA to this point epitomises the sense of urgency that drives oncology drug developers to bring important new medicines to patients in need."
The safety and efficacy of Imbruvica was assessed in an open-label, multi-centre, single-arm Phase Ib/II study (PCYC-1102-CA) carried out in 48 patients with CCL for a median treatment duration of 15.6 months
It was administered at 420mg once-daily until disease progression or until no longer tolerated by the patient.
The ORR and duration of response (DOR) were assessed in the trial according to a modified version of the International Workshop on CLL (IWCLL) criteria by an Independent Review Committee.
While the DOR ranged from 5.6 to 24.2+ months, ORR was 58.3% of patients (95% confidence interval (CI) (%), 43.2, 72.4), all partial responses.
Image: Wright’s stained peripheral blood smear showing chronic lymphocytic leukaemia. Photo: courtesy of Bibi Saint-Pol.
