Pfizer Talzenna is fdated by the U.S. FDA for the treatment of gBRCAm HER2 negative localized advanced or metastasis breast cancer

Pharmaceutical giant Pfizer recently announced that the U.S. Food and Drug Administration (FDA) has approved the targeted cancer drug Talazoparib for the treatment of patients with harmful or suspected harmful reproductive BRCA mutations (gBRCAm), HER2 negative localized advanced or metastatic breast cancer (MBC). For medication, Talzenna's recommended dose is 1 mg once a day or orally, 1mg, with or without food. Previously, the FDA had granted Talzenna priority review eligibility.
approval makes Talzenna the fourth PARAP inhibitor approved by the FDA to compete with AstraZeneca's Lynparza, Clovis' Rubraca and Tesaro's Zejula. It should be noted that patients treated with Talzenna must be tested in an accompanying diagnostic kit approved by the FDA to prove suitable for the treatment. For its part in the European Union, the European Medicines Agency (EMA) is also currently reviewing the application for a market license (MAA) for talazoparib to treat the same adaptive disorder.
approval of Talzenna is based on data from the critical, randomized Phase III clinical study EMBRACA (NCT01945775). The study, conducted in 431 patients with gBRCAm, HER2-negative localized advanced or metastasis breast cancer, assessed the efficacy and safety of talazoparib relative to the standard single-drug chemotherapy option chosen by the physician (initial chemotherapy (PCT): Capathamin, Aibrin, Gissithamin, or Changchun Ruibin. In the study, patients were randomly assigned to talazoparib (1.0mg once a day) or PCT at a 2:1 scale. All patients have known or suspected harmful gBRCA mutations and have received no more than 3 cytotoxic chemotherapy programmes to treat locally advanced or metastasis diseases, as well as a drug and/or yewane in the treatment of new complementary, ancillary, and/or metastasis diseases (unless taboo). The main endpoint was a significant extension of PFS in the talazoparib treatment group compared to the PCT treatment group (medium PFS: 8.6 months vs 5.6 months, HR=0.5) based on progress-free survival (PFS)
data assessed by the Independent Central Review of Blind Law based on the solid tumor response evaluation standard RECIST 1.1 4 (95%CI: 0.41-0.71), p<0.0001), significantly reduced risk of disease progression by 46%, doubled the proportion of patients who achieved full or partial remission (62.6% vs 27.2%, p<0.0001). In addition, the PFS benefits from talazoparib treatment were consistent across pre-designated subgroups, including patients with a history of brain metastasis, patients who had previously received chemotherapy, TNBC patients, and patients with HR-plus. In the study, the rates of stage 3 and above in the talazoparib treatment group ≥10% included anemia (35%), neutral granulocyte reduction (17%), and plateiac reduction (17%).
addition, the FDA approved myriad Genetic Laboratories' accompanying diagnostic kit, BRACAnalysis CDx test, for screening patients suitable for talazoparib treatment, i.e. breast cancer patients with harmful or suspected harmful gBRCAm.
talazoparib is a polyADP-ucose polymerase (PARP) inhibitor. Preclinical studies have shown that talazoparib is highly effective and has a dual mechanism that induces tumor cell death by blocking PARP enzyme activity and capturing PARP at DNA damage points. Currently, talazoparib is being evaluated for gBRCAm breast cancer and early TNBC as well as other types of cancers with DNA Damage Repair (DDR) defects. (Bio Valley)