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Venetoclax Approval Could Open Doors For AbbVie

The speedy green light for AbbVie (NYSE:ABBV) and Roche’s (OTCQX:RHHBY) venetoclax might have come in a small population – patients with relapsed or refractory chronic lymphocytic leukemia with the highly aggressive 17p deletion – but it could act as a springboard for approval in other indications or as part of a combination therapy, where various trials are already under way (see table below).

There is not much doubt about the efficacy of venetoclax, a first-in-class Bcl-2 inhibitor now known as Venclexta. But questions might linger about its safety. If these can be allayed and the drug expanded into broader uses, sales could hit $1.8bn by 2020, according to EvaluatePharma’s consensus of sellside forecasts.

The phase II study on which Venclexta’s approval is based showed an impressive overall response rate of 80%, compared with a 58%...