Why Can’t Dying Patients Get the Drugs They Want?

Excerpt:

“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.”

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NCCN Guidelines Recommend Optune in Combination with Temozolomide as a Category 1 Treatment for Newly Diagnosed Glioblastoma

Excerpt:

“NovoCure (NASDAQ: NVCR) announced today that the National Comprehensive Cancer Network (NCCN) has updated its clinical practice guidelines to recommend Optune® in combination with temozolomide as a category 1 treatment for newly diagnosed glioblastoma (GBM) in its globally recognized Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Central Nervous System Cancers.

“NCCN panel members designated alternating electric field therapy, or Optune, as a Category 1 treatment recommendation for patients with newly diagnosed GBM in conjunction with temozolomide after maximal safe resection and completion of radiation therapy in patients with newly diagnosed GBM.”

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CMS Starts to Cover Broad Cancer DNA Tests, Boosting Foundation, Thermo

Excerpt:

“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.”

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Novel Combo Explored for Rare Brain Tumor

Excerpt:

“Investigators are seeking to determine whether the combination of eflornithine (alphadifluoromethylornithine) with lomustine can improve survival for patients with recurrent anaplastic astrocytoma (AA). A rare form of brain tumor, AA occurs more often in adults aged 30 to 50 years and accounts for 17% of primary malignant brain tumors. This tumor type is even more rare when it recurs, according to Victor A. Levin, MD, emeritus professor of neurooncology at The University of Texas MD Anderson Cancer Center in Houston and a clinical professor at the University of California, San Francisco, School of Medicine.”

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Re-engineered Cold Virus Increases Brain Cancer Patients’ Survival, Phase 1 Trial Shows

Excerpt:

“Re-engineering a common cold virus to attack the deadliest kind of brain tumor extended the survival of patients whose tumor returned after various treatments, including surgery, a Phase 1 clinical trial shows.

“While patients with glioblastoma usually live a median of six months, half were still alive at 9/12 months after receiving the re-engineered virus. And 20 percent lived for three years or longer.”

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A New Regulatory Threat to Cancer Patients

Excerpt:

“The federal government is threatening to limit treatment options for doctors fighting cancer. A regulatory decision due Wednesday from the Centers for Medicare and Medicaid Services could undermine the care delivered to the more than 1.6 million Americans who are diagnosed with cancer each year.”

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Monoclonal Antibody Treatment in Newly Diagnosed Pediatric High-Grade Glioma

Excerpt:

“In a phase II study reported in the Journal of Clinical Oncology, Grill et al found that the addition of bevacizumab (Avastin) to radiotherapy plus temozolomide (RT + TMZ) did not improve event-free survival in pediatric patients with newly diagnosed high-grade glioma.

“In the international open-label study, 121 patients aged 3 to 18 years with localized nonbrainstem disease from 51 sites in 14 countries were randomized between October 2011 and February 2015 to receive RT + TMZ with (n = 62) or without (n = 59) bevacizumab 10 mg/kg every 2 weeks. RT + TMZ consisted of RT at 1.8 Gy 5 days per week and TMZ at 75 mg/m2 per day for 6 weeks followed by a 4 weeks off, then up to twelve 28-day cycles at 150 mg/m2 per day on days 1 to 5 in cycle 1 and 200 mg/m2 per day on days 1 to 5 in cycles 2 to 12. The primary endpoint was event-free survival on blinded central radiology review. Results are reported as of 12 months after the enrollment of the last patient.”

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DNX-2401 Demonstrates “Dramatic” Survival Benefit in Glioma

Excerpt:

“Treatment with the investigational agent DNX-2401 resulted in 20% of a cohort of patients with recurrent malignant glioma surviving more than 3 years from the time of treatment, according to phase I data published in the Journal of Clinical Oncology.

“In the dose-escalation study, patients were enrolled into the treatment-only group A (n = 25) or the treat-resect-treat group B (n = 12). Group A underwent stereotactic biopsy to document recurrence, followed by a single intratumoral injection of DNX-2401 at the assigned dose through the biopsy needle into the contrast-enhancing tumor mass. In group B, stereotactic biopsy and intratumoral injection of DNX-2401 through an implanted catheter was followed 2 weeks later by craniotomy with en bloc tumor resection, and then administration of a second DNX-2401 dose into several locations in the wall of the resection cavity.”

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Tumor-Treating Fields for Glioblastoma Do Not Negatively Impact Quality of Life

Excerpt:

“The addition of tumor-treated fields to standard therapy with temozolomide prolonged deterioration-free survival without negatively influencing health-related quality of life among patients with glioblastoma, according to a secondary analysis of a phase 3 clinical trial published in JAMA Oncology.

“However, tumor-treating fields, or TTFields (Optune, Novocure) — alternating electrical fields delivered via four transducer arrays at an intermediate frequency of 200 MHz (1-3 V/cm) placed on the shaved scalp of patients and connected to a portable medical device — also caused skin irritation in more than half of patients.”

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