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FDA Approves Eli Lilly’s Tau Pathology Drug For Alzheimer’s
Other recent FDA news includes the approval of Eli Lilly and Bristol Myers Squibb’s individual non-small cell lung cancer drugs and the approval of Roche’s liver cancer drug.
FDA recently approved Eli Lilly’s drug, Tauvid, for intravenous injection, the first drug to help image a specific characteristic of Alzheimer’s disease in the brain called tau pathology.
Tau and amyloid proteins are recognized as main indicators of Alzheimer’s disease.
Tau proteins develop in the brain and create neurofibrillary tangles. Tauvid binds to the sites in the brain affected by these proteins and allows the brain to be imaged with a positron emission tomography (PET) scan to help identify the presence of tau pathology, FDA said.
“While there are FDA approved imaging drugs for amyloid pathology, this is the first drug approved for imaging tau pathology, one of the two neuropathological hallmarks of Alzheimer's disease, and represents a major advance for patients with cognitive impairment being evaluated for the condition. “Charles Ganley, MD, director of office of specialty medicine in FDA’s Center for Drug Evaluation and Research said in the announcement.
FDA’s approval is based on the safety and effectiveness of Tauvid evaluated in two clinical studies.
The first study enrolled 156 patients who were terminally ill and found that evaluators reading the Tauvid images had a high probability of correctly evaluating patients with tau pathology. The second study included the same patients as the first plus an additional 18 with terminal illness.
In this study, reader agreement was 0.87 across all 241 patients. A perfect reader agreement would be 1, while no reader agreement would be 0, FDA said.
In a separate analysis that included the 82 terminally ill patients diagnosed after death and the 159 patients with cognitive impairment, reader agreement was 0.90 for the patients in the indicated population and 0.82 in the terminally ill patients.
FDA Approves Roche’s Tecentriq for Individuals With Unresectable Liver Cancer
Roche recently announced that FDA approved Tecentriq for the treatment of individuals with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior therapy.
The approval of the drug was conducted under FDA’s Project Orbis initiative, which reviews oncology medicines among international partners and may allow cancer patients to receive earlier access to products in other countries, FDA said in the announcement.
The FDA approval was based on results from the Phase III IMbrave150 study, which demonstrated that Tecentriq, in combination with Avastin, reduced the risk of death by 42 percent and decreased the risk of disease worsening or death 41 percent, compared with sorafenib.
“For the first-time we have a regimen that markedly improves survival over sorafenib, the standard of care for first-line hepatocellular carcinoma since 2007, and offers patients the opportunity for improved disease control with a favourable tolerability profile,” saidRichard Finn, MD, professor of medicine at the David Geffen School of Medicine at UCLA and director of the signal transduction and therapeutics program at the UCLA Jonsson Comprehensive Cancer Center.
FDA Approves Bristol Myers Squibb Drugs for Metastatic or Recurrent Non-Small Cell Lung Cancer
Bristol Myers Squibb recently announced that FDA approved Opdivo (nivolumab) 360 mg plus Yervoy (ipilimumab) 1mg to be administered with two cycles of platinum-doublet chemotherapy for patients with metastatic or recurrent non-small cell lung cancer (NSCLC).
The drugs are intended for adult NSCLC patients with no EGFR or ALK genomic tumor aberrations, Bristol Myers said.
The application was reviewed under FDA’s Real-Time Oncology Review (RTOR) pilot program, which expects to get treatment to patients in a quick and efficient manner.
The FDA approval is based on a pre-specified interim analysis from the Phase 3 CheckMate-9LA trial where both Opdivo and Yervoy, combined with platinum-doublet chemotherapy treatments, showed superior overall survival versus chemotherapy, Bristol Myers said.
Median overall survival was 14.1 months versus 10.7 months, respectively. At one year, 63 percent of patients treated with the drugs and 47 percent of individuals treated with chemotherapy were still alive.
“The positive findings from CheckMate -9LA demonstrate the benefit of combining dual immunotherapy with limited chemotherapy for NSCLC patients regardless of PD-L1 status. With today’s approval, more patients now have access to an Opdivo + Yervoy-based option and a chance at a longer life,” David P. Carbone, MD, PhD, CheckMate -9LA investigator and director of the James Thoracic Oncology Center at The Ohio State University, said in the announcement.
FDA Approves Eli Lilly’s Metastatic EGFR-Mutated Non-Small Cell Lung Cancer Treatment
Eli Lilly and Company recently announced that FDA approved Cyramza for the treatment of individuals with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR).
Cyramza has now received six FDA approvals to treat specific types of lung, liver, stomach, and colorectal cancers, Eli Lilly noted.
In the US, it is estimated that nearly 15 percent of people diagnosed with NSCLC have an EGFR mutation.
"This CYRAMZA combination regimen represents a new and meaningful treatment option for people with metastatic EGFR-mutated non-small cell lung cancer, and we are proud that it has been approved by the FDA for patients with this disease and the doctors who treat them," Anne White, president of Lilly Oncology, said in the announcement.
Cyramza, in combination with erlotinib, is the first and only FDA approved anti-VEGFR/EGFR TKI combination therapy for metastatic NSCLC.
FDA based its approval on the efficacy and safety from the global, randomized, placebo-controlled Phase 3 RELAY trial where Cyramza demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to placebo.
