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Tag Archives: Pfizer—

BRACAnalysis CDx approved as Talzena companion dx

Oct. 22, 2018—Myriad Genetics announced that the FDA has approved its BRACAnalysis CDx to identify patients with HER2-negative metastatic breast cancer who have a germline BRCA mutation and are eligible for treatment with Pfizer’s PARP inhibitor, Talzena (talazoparib). Talzena is indicated for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated HER2-negative locally advanced or metastatic breast ...

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Therascreen EGFR RGQ PCR kit approved as CDx

Oct. 1, 2018—Qiagen announced that the FDA has approved a PMA supplement expanding the labeling claim of the Therascreen EGFR RGQ PCR Kit to allow its use as a companion diagnostic with Pfizer’s Vizimpro (dacomitinib) for first-line treatment of patients with non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or an exon 21 L858R mutation.

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FDA expands approval of Sutent

Dec. 22, 2017—Pfizer announced the FDA has approved a new indication expanding the use of Sutent (sunitinib malate) to include the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma following nephrectomy. The approval was based on results from the S-TRAC trial, which demonstrated a significant reduction in the risk of a disease-free survival event for ...

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