FDA Approves First-of-a-Kind Test for Cancer-Gene Profiling

Excerpt:

“U.S. regulators have approved a first-of-a-kind test that looks for mutations in hundreds of cancer genes at once, giving a more complete picture of what’s driving a patient’s tumor and aiding efforts to match treatments to those flaws.

“The U.S. Food and Drug Administration approved Foundation Medicine’s test for patients with advanced or widely spread cancers, and the Centers for Medicare and Medicaid Services proposed covering it.

“The dual decisions, announced late Thursday, will make tumor-gene profiling available to far more cancer patients than the few who get it now and will lead more insurers to cover it.”

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Tecentriq Add-On Improved Outcomes in Untreated Advanced Lung Cancer Patients

Excerpt:

“Adding Tecentriq (atezolizumab) to a treatment of Avastin (bevacizumab) and chemotherapy significantly prolonged the time to disease progression or death in people with previously untreated advanced non-squamous non-small cell lung cancer (NSCLC).

“The results stem from a Phase 3 trial of 1,202 people, with data also indicating better overall survival in patients treated with Tecentriq. Improved progression-free and overall survival were the two main trial outcome measures.”

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Intermittent Extended Letrozole Fails in Postmenopausal Breast Cancer

Excerpt:

“An intermittent dosing schedule with extended adjuvant letrozole did not improve disease-free survival (DFS) over continuous treatment with the agent in postmenopausal women with hormone receptor–positive breast cancer, according to the randomized phase III SOLE trial.

” ‘The magnitude of the beneficial effect of 5 years of extended letrozole use in postmenopausal women who have previously received an aromatase inhibitor for 5 years is low,’ wrote study authors led by Marco Colleoni, MD, of the European Institute of Oncology in Milan, Italy. That small effect may be partially due to acquired resistance, and animal studies suggest that such resistance can be reversed by discontinuing treatment.”

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Vulnerability Identified for Subtypes of Glioblastoma

Excerpt:

“Glioblastoma, the most common and aggressive form of brain cancer, typically fails to respond to treatment or rapidly becomes drug resistant. In a paper published online in the journal Cancer Cell on November 30, University of California San Diego School of Medicine researchers identified a strategy that pinpoints a genetically distinct subpopulation of patients with glioblastoma that is particularly sensitive to drugs like cilengitide that target a cell adhesion receptor known as integrin αvβ3.

“Cilengitide was developed based on early studies by David Cheresh, PhD, Distinguished Professor of Pathology at UC San Diego School of Medicine, and colleagues who demonstrated that αvβ3 expression was linked to the progression of glioblastoma. The  was tested in clinical trials but production was halted in 2014 when it failed to show significant improvement in overall survival among participants during phase III trials.”

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FDA Aims to Expand Early-Approval Program for Promising Drugs

Excerpt:

“The Food and Drug Administration wants to help patients get faster access to promising cancer treatments.

“The agency is preparing proposals that would expand an accelerated-approval program for lifesaving medications, FDA Commissioner Scott Gottlieb told House lawmakers on Thursday.

“Drugmakers can seek rapid conditional approval for treatments for cancer or other serious diseases based on evidence that a drug is likely to extend patient survival. Later trials once such a drug is on the market are necessary to prove the survival benefit.”

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Glembatumumab Vedotin Induces Promising DCR in Uveal Melanoma

Excerpt:

“According to results from the phase II NCI9855 study, presented at the 2017 World Congress of Melanoma, glembatumumab vedotin (CDX-011) induced a 61% disease control rate (DCR) in patients with metastatic uveal melanoma, despite a low a low objective response rate (ORR) of 6%.

“There were no complete responses, 2 (6%) partial responses, and 17 patients (55%) with stable disease. Twelve patients (39%) experienced disease progression.”

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Second Course of Radium-223 Demonstrates Promising Results in mCRPC

Excerpt:

“According to results of a phase I/II study, men with metastatic castration-resistant prostate cancer (mCRPC) who received a second course of radium-223 (Xofigo) experienced minimal hematologic toxicity and low radiographic bone progression rates.

“In the study, 29 of 44 patients (66%) received the full course of 6 injections. Median time to total alkaline phosphatase was not reached. Median time to PSA progression was 2.2 months.”

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Cancer Drug Starts Clinical Trials in Human Brain-Cancer Patients

Excerpt:

“A drug that spurs cancer cells to self-destruct has been cleared for use in a clinical trial of patients with anaplastic astrocytoma, a rare malignant brain tumor, and glioblastoma multiforme, an aggressive late-stage cancer of the brain. This phase Ib trial will determine if the experimental drug PAC-1 can be used safely in combination with a standard brain-cancer chemotherapy drug, temozolomide.

“The trial is approved for patients who have seen their cancer progress after first-line therapy. This is an extension of an ongoing human phase I clinical trial of PAC-1 alone in patients with various late-stage cancers. Phase I  are designed to test the safety of new drugs in human patients.”

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Study Questions Exclusion of Cancer Survivors from Trials

Excerpt:

“A quarter of newly diagnosed cancer patients 65 or older are survivors who had a prior cancer — often preventing them from participating in clinical trials, researchers from UT Southwestern’s Simmons Cancer Center have found.

“The UT Southwestern scientists found that 11 percent of individuals ages 20-64 had a history of a prior cancer, and 25 percent of individuals 65 or older had a history of a prior cancer.

“As the number of cancer survivors grows, more individuals are being excluded from cancer clinical trials that could benefit them when diagnosed with a second cancer.”

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