Gilead Pulls Idelalisib Indications From US Market After Failing to Confirm Clinical Benefit

After failing to complete the requisite confirmatory trials following accelerated approval, Gilead has announced it will withdraw two indications for its cancer drug from the U.S. market.

In 2014, idelalisib was granted accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of relapsed follicular lymphoma (FL) and relapsed small lymphocytic leukemia (SLL). The pivotal trials demonstrated objective response rates of 54% for patients with FL and 58% for patients with SLL. Continued approval for these indications was contingent upon providing evidence supporting confirmation of clinical benefit in FL and SLL. The company noted that “enrollment into the confirmatory study has been an ongoing challenge,” leading to its decision to voluntarily withdraw these indications from the U.S. market.

In 2014, idelalisib was also approved for the treatment of relapsed chronic lymphocytic leukemia (CLL) and will remain on the market for that indication.

Idelalisib is a first-in-class inhibitor of PI3K delta, a protein that is overexpressed in B-cell malignancies and enables the viability, proliferation, and migration of these cancer cells.

This decision does not affect idelalisib’s marketing authorizations to treat CLL and FL in the E.U., U.K., Canada, Australia, New Zealand, and Switzerland.

Source: Gilead press release, January 21, 2022.