Melanoma "immune-targeted" therapy! Roche Tecentriq three-drug program approved by the U.S. FDA to treat BRAF V600-positive patients!

July 31, 2020 // Roche has announced that the U.S. Food and Drug Administration (FDA) has approved the anti-PD-L1 therapy Tecentriq (atezolizumab) joint targeting of the anti-cancer drugs Cotellic (cobimetinib) and Zelboraf (vemurafenib) for the treatment of patients with advanced melanoma with the BRAF V600-positive mutation.
the safety of the Tecentriq combination drug is consistent with the known safety of each drug. applications
Tecentriq's joint drug regimen were approved through the priority review process and the FDA Orbis pilot project. the
Oribis project is an initiative launched by the FDA Center of Excellence for Oncology in September 2019 to provide a collaborative framework for the FDA and its international regulatory agencies to jointly submit and review oncology drugs. "When treated with a combination of cancer immunotherapy and targeted therapy, patients with advanced melanoma who are positive at the BRAF V600 mutation survive for more than 15 months without worsening the disease," said Dr. Levi Garraway, chief medical officer and global product development officer at
Roche.
fda approval of the Tecentriq combination drug today is a significant step forward for many patients with advanced melanoma.
" approval, based on the results of the Phase III IMspire 150 study.
this is a double-blind, placebo-controlled study conducted in patients with previously untreated (initial) BRAF V600 mutation-positive advanced melanoma, evaluating the efficacy and safety of Tecentriq's combination of Cotellic and Zelbobo.
results showed that the study reached the primary endpoint: significantly longer progression survival (PFS) (median PFS: 15.1 monthvs vs 10.6 months), disease progression or death risk (HR?0.78, 95%CI:0.97;
the study, the observed safety of combination drugs was consistent with the known safety of each drug.
patients treated with tecentriq-Cotellic-Zelboraf program, the most common adverse reactions (incidence of 20 percent) were rashes (75 percent), musculoskeletal pain (62 percent), fatigue (51 percent), liver toxicity (50 percent), fever (49 percent), nausea (30 percent), itching (26 percent), edema (26 percent), stomatitis (23 percent), hypothyroidism (22 percent) and photosensitivity (21 percent).
Tecentriq is an anti-PD-L1 tumor immunotherapy with an active drug ingredient called atezolizumab, a monoclonal antibody that targets the PD-L1 protein and is designed to bind to the surface of tumor cells and tumor-immersed immune cells, blocking its binding to PD-1 and B7.1 receptors.
by inhibiting PD-L1, Tecentriq can reactivate T cells.
Cotellic is an oral small molecule MEK1/2 inhibitor, discovered by Exelixis and developed jointly by Roche and Exelixis.
Zelboraf, a powerful BRAF inhibitor that inhibits certain types of mutant braF, is the first approved drug of this type, developed under a 2006 licensing and cooperation agreement between Roche and Plexxikon, a joint company of First Three.
MEK and BRAF are key protein kinases in the MAPK Signaling Pathway (RAS-RAF-MEK-ERK).
studies have shown that this pathway regulates a variety of key cellular activities, including cell proliferation, differentiation, survival, and angiogenesis.
proteins in this signaling pathway have been shown to be abnormally active in many cancers, such as melanoma, colorectal cancer and thyroid cancer.
currently available, Cotellic-Zelboraf combination therapy has been approved in several countries around the world to treat melanoma patients whose tumors have spread to other parts of the body or cannot be surgically removed and carry the BRAF V600 mutation.
Roche has developed an extensive clinical trial development program for Tecentriq and is currently conducting a number of studies, including phase III of lung cancer, urogenital cancer, skin cancer, breast cancer, gastrointestinal cancer, gynecological cancer, and head and neck cancer.
these studies are evaluating Tecentriq as a monodrug therapy and in combination with other drugs.
() Original source: FDA Approves Genentech's Tecentriq plus Cotellic and Zelboraf for People With With Advanced.