Congratulate! Identification of two breakthrough therapies of Pfizer anticancer drugs harvested on the same day

Source: Wuxi apptec May 30, 2018 today, Pfizer announced that xalkori (crizotinib) has been awarded two breakthrough therapies by FDA at the same time In one of the findings, xalkori was applied to patients with metastatic non-small cell lung cancer (NSCLC) who had altered met exon 14, a transmembrane tyrosine kinase receptor expressed in a variety of cells, during or after platinum-based chemotherapy In another finding, xalkori can be used to treat relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) patients with positive anaplastic lymphoma kinase (ALK) Lung cancer is the main cause of cancer death in the world NSCLC, which accounts for 85% of lung cancer cases, is still a difficult problem to treat, especially when tumor metastasis occurs Because about 75% of NSCLC patients were diagnosed with metastasis or advanced stage, their five-year survival rate was only 5% In NSCLC patients, about 3% of them had met exon 14 changes ALCL is a rare non-Hodgkin's lymphoma (NHL), but it is one of the common subtypes of T-cell lymphoma ALCL accounts for about 2% of all NHL and 20% of all T-cell lymphoma Patients with systemic ALCL can be divided into two types: positive or negative Positive ALCL is common in children and adolescents Although both are treated as invasive lymphoma, many patients still experience relapse or need other treatment These patients are in urgent need of new and effective treatment to alleviate the disease Xalkori is an oral competitive ALK, met and ros1 inhibitor Because of the high homology of ros1 and alk in kinase domain, ALK inhibitors including xalkori also have significant effect on ros1 positive tumors Currently, xalkori has been approved in the United States to treat patients with metastatic NSCLC who are ALK positive or ros1 positive It has been proved to be an innovative first-line treatment standard for global ALK positive and ros1 positive NSCLC patients, and also the only treatment scheme approved by FDA for both ALK positive and ros1 positive metastatic NSCLC Xalkori would be the only tyrosine kinase inhibitor (TKI) to show efficacy in three independent biomarker driven NSCLC indications if it was approved for use in patients with metastatic NSCLC with altered met exon 14 Xalkori obtained a breakthrough treatment for patients with metastatic NSCLC with the change of met exon 14, which was based on the results of the phase 1 clinical trial profile 1001 of the expanded cohort In this study, xalkori showed antitumor activity The breakthrough therapy of xalkori in patients with recurrent or refractory systemic ALCL with positive ALK is based on the results of advl0912 test and a8081013 test Advl0912 study is a primary clinical phase 1 / 2 trial conducted by children's tumor tissue in children with ALCL It evaluates the safety and tolerable maximum dose of xalkori, and tests its therapeutic effect on recurrent or refractory solid tumors The a8081013 study evaluated the efficacy of xalkori in the treatment of children and adults with ALK positive advanced cancer, excluding NSCLC, but including patients with recurrent and refractory ALCL In both trials, xalkori showed convincing antitumor activity in both children and adults "Biomarker driven therapies are changing the way we treat cancer and helping us ensure that patients have access to drugs that are appropriate for their disease," said Dr mace Rothenberg, chief oncology development officer, Pfizer global product development Xalkori's breakthrough treatments confirm Pfizer's commitment to the development of precision medicine and provide cancer patients with these mutations with drugs that may change their lives " We look forward to the FDA's two breakthrough therapies that will enable xalkori to benefit more cancer patients.