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.
Read More »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 ...
Read More »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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