FDA approves efficacy supplement for Pfizer's Talzenna

The U.S. Food and Drug Administration approved a supplemental new drug application for Talzenna, the brand name for talazoparib tosylate, with an action date of October 26, 2026, according to FDA drug approval records.

The submission, numbered 14, was classified as an efficacy supplement and reviewed under priority review status, and its status is listed as approved as of the submission status date.¹

Pfizer is the sponsor of the application, which is filed under NDA211651, per the FDA record.

The approved product line covers Talzenna oral capsules across six strengths. These include capsules containing talazoparib tosylate at strengths equivalent to 0.1 mg, 0.5 mg, 0.25 mg, 0.35 mg, 0.75 mg, and 1 mg of base.¹

The FDA record does not specify the particular indication or clinical data supporting this efficacy supplement, nor does it detail the specific labeling changes associated with the approval. Readers seeking the clinical rationale or updated indication language should consult the full prescribing information or Pfizer's own disclosures once available, as the drugs@FDA record provided here contains only the administrative approval details: sponsor, application number, submission classification, priority designation, and approval date.