April 8, 2019
FDA Approves Atezolizumab for Extensive-Stage Small Cell Lung CancerBookmarkEmma Shtivelman, PhD
“On March 18, 2019, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq) in combination with carboplatin and etoposide for the first-line treatment of adult patients with extensive-stage small cell lung cancer.
Approval was based on the IMpower133 study, a randomized (1:1), multicenter, double-blind, placebo-controlled trial in 403 patients with extensive-stage small cell lung cancer who received no prior chemotherapy for extensive stage disease and had ECOG performance status 0 or 1.”
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April 8, 2019
Atezolizumab/Nab-Paclitaxel Approved by the FDA for PD-L1+ TNBCBookmarkEmma Shtivelman, PhD
“An accelerated approval has been granted by the FDA for the combination of atezolizumab (Tecentriq) and nab-paclitaxel (Abraxane) as a frontline treatment for patients with unresectable locally advanced or metastatic PD-L1–positive triple-negative breast cancer (TNBC).
“The approval is based on the phase III IMpassion130 trial, in which the addition of the PD-L1 inhibitor atezolizumab to nab-paclitaxel reduced the risk of progression or death by 40% compared with nab-paclitaxel alone in this patient population.”
January 7, 2019
Roche’s Tecentriq Wins Speedy U.S. FDA Review for Small Cell Lung CancerBookmarkEmma Shtivelman, PhD
“Swiss group Roche Holding AG said on Wednesday its Tecentriq immunotherapy mixed with chemotherapy won priority review from the U.S. regulator for treating a type of lung cancer, a potential boost to the drug that has been trailing rivals’ revenues.
“The announcement comes after Roche in September said patients with untreated extensive-stage small cell lung cancer (SCLC) lived a median 12.3 months after getting the Tecentriq cocktail, compared to 10.3 months for those getting chemotherapy alone.
“Winning the speedy review from the U.S. Food and Drug Administration sets up possible U.S. approval for Tecentriq in this indication by March 18, the drugmaker said in a statement.”
October 1, 2018
Roche’s Tecentriq, Trailing Rival Drugs, Lifts Lung Cancer SurvivalBookmarkEmma Shtivelman, PhD
Excerpt from Reuters:
“A drug cocktail with Roche’s Tecentriq added two months to small-cell lung cancer patients’ lives, according to a study, aiding the Swiss group’s bid to win approval in a niche disease area before rivals that now dominate the immunotherapy market.
“Patients with untreated extensive-stage small-cell lung cancer (SCLC), where cancer has spread, lived a median 12.3 months after getting Tecentriq plus chemotherapy.”
October 1, 2018
First-Line Atezolizumab Plus Chemotherapy Improves PFS for Lung CancerBookmarkEmma Shtivelman, PhD
Excerpt from Healio:
“The addition of frontline atezolizumab to carboplatin or cisplatin plus pemetrexed improved PFS among patients with non-small cell lung cancer, according to interim results from a global phase 3 randomized trial presented at International Association for the Study of Lung Cancer’s World Conference on Lung Cancer.
“IMpower132 is an open-label study of atezolizumab (Tecentriq, Genentech) — a PD-L1 inhibitor — among 578 chemotherapy-naive patients with stage IV nonsquamous NSCLC. Exclusion criteria included EGFR or ALK mutations, untreated central nervous system metastases, autoimmune disease and prior exposure to immunotherapy.”
August 22, 2018
Study Describes Design, Validation of Foundation Medicine’s Blood-Based TMB TestBookmarkEmma Shtivelman, PhD
Excerpt from GenomeWeb:
“Researchers from Genentech, Foundation Medicine, UC Davis, and other medical centers, have published a report on the development and early validation of Foundation’s planned blood-based tumor mutational burden test.
“Appearing today in Nature Medicine, the study describes the development of the test and its characteristics, and its retrospective validation in two cohorts. Investigators demonstrated, by applying the assay to samples from two clinical trials, that blood-based TMB (bTMB) could reproducibly identify lung cancer patients who respond to immunotherapy treatment with Roche/Genentech’s atezolizumab (Tecentriq).”