Roche submits a license to the FDA to supplement biologics to the anti-cancer drug Kadcyla

recently, Roche, the swisspharmaceutical(http://giant, announced that it had submitted to the u.SFood andDrug(http://Administration (
FDA(http://a supplementary biological product license (sBLA) for approval of Kadcyla for treatment of preoperative lying with preoperative breast cancerbefore that, the FDA had qualified Kadcyla for the breakthrough drug for the indicationsAbout Kadcyla
Kadcyla is one of three newnew drug(http://developed by Roche for HER2 signal ingestpathways, and the other two are Hercetin and PerjetaThe introduction of these three drugs has revolutionized the clinical treatment model for HER2-positive breast cancerKadcyla, an HER2 targeted therapy, was approved in 2013 and has been approved in 104 countries worldwide to dateThe drug is made up of trastuzumab (trastuzumab, hercetine active pharmaceutical ingredient) and(http://cell poison DM1 of Theof ImmunoGen, which delivers DM1 to HER2-positive breast cancer cells through a stable linkKadcyla has two anti-cancer properties: HER2 inhibitory of qutoberidad and cytotoxicity of DM1Theof the study is based on data from phase III clinical studies on KATHERINEThe study showed that in PATIENTS
WITH HER2-POSITIVE EARLY BREAST CANCER WITH RESIDUAL DISEASE AFTER RECEIVING THE NEW COMPLEMENTARY TREATMENT, KADCYLA-ASSISTED THERAPY SIGNIFICANTLY REDUCED THE RISK OF RELAPSE OR ALL-CAUSE DYSM OF IMMERSION BREAST CANCER (SURVIVAL OF NON-IMMERSION DISEASE, IDFS) BY 50% COMPARED TO HERCEPTIN-ASSISTED TREATMENT (HR-0.50,95% CI: 0.39-0.0001)After 3 years of treatment, 83.3 percent of patients in the Kadcyla treatment group had no recurrence of breast cancer, compared with 77.0 percent in the Hercetin treatment group, an absolute improvement of 11.3 percentin terms of safety, Kadcyla's most common level 3-4 adverse events ( - 1%) were platelet reduction, hypertension, radiation skin damage, numbness of the hands or feet, tingling or pain, neutrophil reduction, reduced blood potassium levels, fatigue, and red blood cell reduction