AbbVie’s Imbruvica scoops up 11th FDA approval with chronic lymphocytic leukaemia/small lymphocytic lymphoma nod

pharmafile | April 22, 2020 | News story | Research and Development, Sales and Marketing Cancer, FDA, imbruvica, leukaemia 

AbbVie’s Imbruvica (ibrutinib) has scored its 11th FDA approval, this time in combination with rituximab for the treatment of chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) in previously untreated patients. The drug was first approved back in 2013.

“With eleven FDA approvals in six years, this latest CLL label update for Imbruvica further underscores the impact of this important medicine in the first-line setting,” commented Dr Danelle James, Clinical Development Lead for the drug. “Imbruvica enables long-term disease management and now has demonstrated superior progression-free survival compared to a standard chemoimmunotherapy regimen. Today, many patients who were previously considered appropriate for chemotherapy now have an alternative treatment option.”

The Phase 3 data used in support of this latest approval were drawn from a study conducted by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and sponsored by the National Cancer Institute (NCI). They indicated that CCL patients treated with Imbruvica and rituximab “significantly improved” progression-free survival at a median follow-up time of 37 months, compared to patients treated with a chemotherapy regimen of fludarabine, cyclophosphamide and rituximab (FCR).

However, the findings also showed that, at a median follow-up of 49 months, 23 of the 529 participants had died – with 11 in the Imbruvica group and 12 in the FCR group – and median overall survival had not been reached.

“The gold-standard first-line treatment option for many patients with chronic lymphocytic leukaemia who were fit enough to tolerate an aggressive treatment course had been the intravenous chemoimmunotherapy of FCR – that is, until today,” remarked Dr Brian Koffman, Chief Medical Officer and Executive Vice President at the CLL Society. “The FDA approval of ibrutinib and rituximab regimen is welcome news for these previously untreated patients who have been looking forward to a non-chemotherapy treatment option.”

Matt Fellows

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