The mAb is undergoing evaluation in a Phase 3 study (NCT01697072) of chemotherapy (epirubicin, cisplatin and capecitabine) with rilotumumab or placebo for untreated advanced MET-positive gastric or gastresophageal junction adenocarcinoma. obinutuzumab) transitioned to either the market or regulatory review. Biocon announced in January 2013 that this marketing application for itolizumab (Alzumab) had been authorized by the Drugs Controller General of India. Itolizumab is usually a humanized mAb that targets CD6, which is usually predominantly expressed by T cells and a subset of B cells. In the 52-week TREAT-PLAQ study conducted in India, interim results indicated that patients with psoriasis area severity index (PASI) of > 20 at baseline had PASI 75-response (i.e., improvement from baseline of 75%) rates of 43% and 54% at week 12 and 28, respectively. Patients in the fixed dose treatment arm of the study received 1.6 mg/kg every two weeks for 12 weeks followed by Alfacalcidol 1.6 mg/kg every four weeks for 16 weeks; those in the induction dose arm received 0.4 mg/kg every two weeks for 12 weeks followed by 1.6 mg/kg every four weeks for 16 weeks. Biocon is usually reportedly planning to launch itolizumab in India as a treatment for moderate-to-severe psoriasis in the JulySeptember 2013 quarter. The company has indicated that itolizumab has also shown promising efficacy in other autoimmune disorders, including rheumatoid arthritis (RA) and multiple sclerosis (MS). In February 2013, trastuzumab emtansine (KadcylaTM; Genentech/Roche) was approved by the US Food and Drug Administration (FDA) as a treatment for human epidermal growth factor receptor (HER)2-positive metastatic breast cancer. Trastuzumab emtansine is an antibody-drug conjugate (ADC) comprising trastuzumab (Herceptin; Genentech/Roche) linked to ImmunoGens DM1 maytansinoid drug. The ADC is the third anti-HER2 monoclonal antibody (mAb) on the US market. The parental trastuzumab was first approved in 1998 and anti-HER2 pertuzumab (PERJETA; Genentech/Roche) was first approved in 2012 as treatments for HER2-positive metastatic breast cancer. In the European Union, trastuzumab and pertuzumab are approved, and trastuzumab emtansine is usually undergoing regulatory review. Trastuzumab emtansine is usually approved for patients who were previously treated with trastuzumab and taxanes. It Rabbit Polyclonal to 5-HT-1F is currently also undergoing Alfacalcidol evaluation in the Phase 3 MARIANNE study (NCT01120184) of trastuzumab emtansine and pertuzumab vs. trastuzumab plus a taxane in patients with metastatic Alfacalcidol breast cancer; the Phase 3 TH3RESA study (NCT01419197) of trastuzumab emtansine compared with treatment of physician’s choice in patients with HER2-positive metastatic breast cancer who have received at least two prior regimens of HER2 directed therapy; and the Phase 3 KATHERINE study (NCT01772472) of trastuzumab emtansine vs. trastuzumab as adjuvant therapy for patients with HER2-positive primary breast cancer who have residual tumor present pathologically in the breast or axillary lymph nodes following preoperative therapy, which was initiated in April 2013. In addition, the safety and efficacy of the mAb are being evaluated in an adaptive Phase 2/3 study (NCT01641939) of patients with previously treated, locally advanced or metastatic HER2-positive gastric cancer, including adenocarcinoma of the gastroesophageal junction. In early March 2013, Takeda Pharmaceutical Company announced that they submitted a marketing authorization application to the European Medicines Agency for vedolizumab, a gut-selective, anti-47 humanized mAb intended as a treatment for adults with moderate-to-severe active ulcerative colitis (UC) and Crohn disease (CD). The application included data from four Phase 3 clinical studies, GEMINI I, GEMINI II, GEMINI III and GEMINI Long-term Safety, that evaluated the efficacy and safety of vedolizumab in moderately to severely active CD and UC patients who had failed to respond to treatment with at least one conventional or anti-tumor necrosis factor Alfacalcidol drug. In late April 2013, Lilly announced that they received Fast Track designation Alfacalcidol from the FDA for ramucirumab, a human IgG1 that targets vascular endothelial growth factor receptor-2, and that they initiated a rolling submission of a licensing application of the mAb as.