Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA approves new drug for diffuse large B-cell lymphoma

Publish date:: August 28, 2020

Key clinical point: FDA grants accelerated approval to tafasitamab-cxix for diffuse large B-cell lymphoma.

Major finding: The overall response rate in 71 DLBCL patients was 55% (95% CI: 43%, 67%), with complete responses in 37% and partial responses in 18% of patients.

Study details: Accelerated approval based upon pivotal L-MIND (NCT02399085) trial, which assessed 81 patients in an open, single arm.

Disclosures: No conflicts were reported.

Citation:

U.S. Food & Drug Administration. 2020;31 July: Drug approval.

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