“ASCO and Friends of Cancer Research (Friends) have submitted recommended language to the U.S. Food and Drug Administration (FDA) for five guidance documents on ways to broaden eligibility criteria for cancer clinical trials. The recommendations are part of an ASCO and Friends collaboration to broaden eligibility for participating in clinical trials by addressing five specific areas: minimum age requirements for trial enrollment, HIV/AIDS status, brain metastases, organ dysfunction, and prior and concurrent malignancies.”
“Midgut neuroendocrine tumors are a rare type of cancer that develops in the small intestine and colon. Roughly 12,000 people are diagnosed with this disease each year. In January, the United Stated Food and Drug Administration approved Lutathera, a first-of-its-kind peptide receptor radionuclide therapy. The injection consists of a somatostatin analog combined with a radioactive isotope that directly targets neuroendocrine tumor cells.
“Dr. Jonathan Strosberg, head of Neuroendocrine Tumor Program at Moffitt ‘Treatment options have been limited for patients with neuroendocrine tumors and toxicities of treatment can often outweigh the benefit. Our studies have shown Lutathera is an effective option to treat tumor progression and also provide patients with a better quality of life,’ said Jonathan R. Strosberg, M.D., head of the Neuroendocrine Tumor Program at Moffitt Cancer Center.”
“Healthcare informatics firm Massive Bio has enrolled its first patient in a global registry it launched as part of a new clinical trial matching system that seeks to connect patients to appropriate biomarker-based clinical trials using information such as clinical history and genomic testing results.
“Previously, Massive Bio offered its clinical trial matching capability as part of a broader oncology clinical decision support system through which it provides treatment guidance and expert recommendations primarily to oncologists working in community practices. By separating the clinical trial matching component, the company hopes to broaden its market reach, said Massive Bio CEO and Cofounder Selin Kurnaz. The company also hopes the new tool will appeal to contract research organizations, molecular diagnostics companies, and patients themselves.”
“At first glance, a bill passed by the House of Representatives this week seems like the kind of thing anyone could get behind.
“Known as the “Right to Try” legislation, it would allow terminally ill patients access to experimental drugs without the approval of the Food and Drug Administration.
“But the bill and a similar one passed last summer by the Senate do little to address the main barrier that patients face in getting unapproved treatments: permission from the drug companies themselves.”
“The Centers for Medicare & Medicaid Services, which administers the federal Medicare insurance program, will begin covering FDA-approved diagnostic tests that scan tumors for a range of genetic mutations. The news is a boost for companies like Foundation Medicine and Thermo Fisher Scientific, who are among the few firms with such tests on the market.
“Late Friday, the CMS said that, going forward, it will start to reimburse for tests that use DNA sequencing technology to map the tumors of patients with advanced cancers once approved by the FDA. Two of the already-approved tests fitting this description are FoundationOne CDx, from Cambridge, MA-based Foundation, and Oncomine Dx Target Test, from Waltham, MA-based Thermo Fisher Scientific (NYSE: TMO). FoundationOne CDx looks for 324 cancer-related alterations in patients’ DNA. Foundation amasses a report based on the results and sends it to doctors, who use the data to suggest possible treatments. Oncomine detects 23 genetic alterations associated with non-small cell lung cancer.”
“Cabozantinib (Cabometyx) demonstrated promising clinical activity in patients with carcinoid tumors and pancreatic neuroendocrine tumors (NETs) in a phase II trial.
“Patients with advanced carcinoid tumors (n = 41) or pancreatic NETs (n = 20) were enrolled in parallel cohorts. Both groups received 60 mg of oral cabozantinib daily and were restaged every 2 months for the first 6 months, and then every 3 months.”
“Several emerging agents are rapidly advancing the treatment paradigm for patients with neuroendocrine tumors (NETs).
“Lutathera (lutetium Lu 177 dotate) was approved by the FDA in January 2018 for patients with somatostatin receptor–positive gastroenteropancreatic NETs. The approval follows the findings of the phase III NETTER-1 trial, which demonstrated a 79% reduction in the risk of progression or death with Lutathera compared with octreotide LAR.”
“The U.S. Food and Drug Administration today approved Lutathera (lutetium Lu 177 dotatate) for the treatment of a type of cancer that affects the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This is the first time a radioactive drug, or radiopharmaceutical, has been approved for the treatment of GEP-NETs. Lutathera is indicated for adult patients with somatostatin receptor-positive GEP-NETs.”
“Clinical trials of new anti-cancer therapies have often excluded patients whose disease has spread to the brain or central nervous system (CNS) or, if such patients were allowed on trial, trials have often failed to clearly capture information on the drug’s effect in the brain. Today new guidelines from an international, multidisciplinary group published in the journal Lancet Oncology describe how to most appropriately address cancer patients with CNS involvement within clinical trials of anti-cancer drugs.”