Tanja Obradovic on FDA Approval for Pfizer’s Talzenna with Xtandi in HRR-Mutated mCRPC
Tanja Obradovic, Oncology Medical Strategy Advisor at Mercurial AI, shared a post on LinkedIn:
“Just delivered FDA decision to grant updated labeling to Pfizer with the inclusion of final overall survival (OS) data for the Talzena (talazoparib) in combination with Xtandi (enzalutamide) to the existing indication for the treatment of adults with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) is in agreement with recent ODAC position. FDA approval did not expand the indication to include patients with non-HRR gene mutated mCRPC.
Important implication for the clinical strategy is positioning of the agency on the need for a pre-respecified, statistically powered analysis of responses in the group negative for the biomarker (in this case non-HRR mutated subgroup). For a long time this approach has been communicated as the most appropriate when wide all-comers label is planned and we may be seeing renewed emphasis by FDA.
Along similar thinking interesting to point recent FDA positioning on Keytruda approval few weeks ago in resectable head and neck cancer that limited treatment to PD-L1 ≥1% population in spite of Merck arguing at AACR2025 that the supporting Keynote-689 study showed benefit in all-comers. That claim was technically correct based on statistics, but exploratory evaluation indicated that responses of PD-L1 expressers were driving up the result across the entire patient population.”
More posts featuring Tanja Obradovic.
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