J&J pulls Imbruvica combo filing in EU as EMA cites potential ‘serious side effects’

A committee of the European Medicines Agency (EMA) said that Johnson & Johnson (NYSE:JNJ) withdrew its application seeking expanded approval of blood cancer drug Imbruvica on Dec. 13, 2022.

J&J’s unit was seeking approval of Imbruvica, a product by J&J and AbbVie (ABBV), in combination with bendamustine and rituximab — sold as Rituxan by Roche’s (OTCQX:RHHBY) (OTCQX:RHHBF) and Biogen’s (BIIB) — to treat patients with previously untreated mantle cell lymphoma (MCL) who cannot have an autologous stem cell transplantation (ASCT).

The EMA’s Committee for Medicinal Products for Human Use (CHMP) said the agency evaluated the company’s application and had certain questions. The company submitted responses but the EMA still had some issues.

The EMA added that it had some concerns and its provisional opinion was that Imbruvica combo could not have been authorized for the particular use.

The agency noted that the benefits of the Imbruvica combo were limited in the proposed use and there were concerns about potential serious side effects, including a higher risk of serious infections.

The agency also considered that it would be difficult to select patients not fit enough for ASCT but still fit enough that the benefits of the combination would outweigh its risks.

J&J’ unit thus withdrew the application noting that the agency considered the data insufficient to approve the Imbruvica combo, according to the CHMP.