AbbVie and Janssen voluntarily withdraw Imbruvica from accelerated approvals for MCL and MZL

AbbVie (NYSE:ABBV) and Janssen Pharmaceutical (NYSE:JNJ) have revealed their intent to voluntarily withdraw the accelerated approvals for Imbruvica (ibrutinib) for patients with mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL) in the U.S. 

Ibrutinib is a selective Bruton’s tyrosine kinase (BTK).

The main reasons for the move relate to FDA’s request for additional studies to confirm clinical benefits that relate to the accelerated approval status granted by the FDA for MCL and MZL. Initially, FDA authorized the accelerated approval program for the two indications following the publication of positive overall response rate data in phase 2 trials. 

While the phase 3 shine study in previously untreated MCL met its primary endpoint of progression-free survival, there was an increased rate of adverse reactions when combining Imbruvica and chemotherapy  compared to the placebo-controlled arm. 

Conversely, the phase 3 SELENE study in re…

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Janssen looks to win new indication in Europe for Imbruvica for untreated mantle cell lymphoma 

Johnson & Johnson‘s Janssen unit (NYSE:JNJ) has filed a submission of a Type II variation application to the European Medicines Agency (EMA) for the potential approval of Imbruvica (ibrutinib) with bendamustine and rituximab (BR) to treat adults with previously untreated mantle cell lymphoma (MCL).

The indication would cover patients who are not suitable for autologous stem cell transplantation (ASCT).

Bendamustine is a chemotherapy drug while and rituximab is a monoclonal antibody that slows or stops cancer growth.

JNJ shares ticked up 0.38% to $169.36 today.

Ibrutinib was jointly developed by J&J’s Janssen Biotech unit and Pharmacyclics LLC, an AbbVie company.

Image courtesy of Janssen

In the U.S, the drug first won approval for mantle cell lymphoma in 2013. The drug has won a series of new indications since then.

A daily Bruton’s tyrosine kinase…

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