Tag Archives: Pfizer

October 2023—The FDA approved bosutinib (Bosulif, Pfizer) for pediatric patients who are one year old and older with chronic phase Ph+ chronic myelogenous leukemia that is newly diagnosed or resistant or intolerant to prior therapy. Efficacy was evaluated in the BCHILD trial (NCT04258943), a multicenter, nonrandomized, open-label trial conducted to identify a recommended bosutinib dose in pediatric patients with newly diagnosed chronic phase Ph+ CML and resistant or intolerant Ph+ CML; estimate the safety, tolerability, and efficacy; and evaluate bosutinib pharmacokinetics in this patient population.

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 ...

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.