Array BioPharma Announces FDA Acceptance of Binimetinib NDA for Patients with Advanced NRAS-Mutant Melanoma

Excerpt:

“Array BioPharma (Nasdaq: ARRY) today announced that the FDA has accepted its New Drug Application (NDA) for binimetinib with a target action date under the Prescription Drug User Fee Act (PDUFA) of June 30, 2017.  Array completed its NDA submission of binimetinib in late June 2016 based on findings from the pivotal Phase 3 NEMO (NRAS MELANOMA AND MEK INHIBITOR) trial in patients with NRAS-mutant melanoma.  The FDA also indicated that it plans to hold an advisory committee meeting (ODAC) as part of the review process. As previously reported, Array is currently preparing for an Application Orientation Meeting (AOM) with the FDA in September 2016, which it expects will include a discussion of the NDA package including clinical risk / benefit.”

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Novel Findings Support Original Categorization of HER2

Excerpt:

“The original classifications of human epidermal growth factor receptor 2 (HER2) categorization by fluorescent in situ hybridization (FISH) have been supported by recent data, according to a report published online Aug. 29 in the Journal of Clinical Oncology.

“Michael F. Press, M.D., from the University of Southern California Norris Comprehensive Cancer Center in Los Angeles, and colleagues reevaluated the HER2 FISH status of patients from Breast Cancer International Research Group (BCIRG)-005/006/007 clinical trials according to current American Society of Clinical Oncology and the College of American Pathologists (ASCO-CAP) guidelines, which designate five groups based on HER2 FISH ratio and average HER2 gene copy number per tumor cell. Data were included for 10,468 patients.”

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Waiting for Cancer

Excerpt:

“With cancer, there are generally two scenarios – you either have it or you don’t. But I am somewhere in the middle, stuck inside a vortex. I don’t have cancer, but as a notable breast surgeon told me, ‘For you, it’s not a matter of if you’ll get it, but when.’ And so I find myself on permanent standby… just waiting.

“While many women at risk for cancer opt to have themselves tested for the BRCA gene mutation, which significantly increases one’s risk of developing breast, ovarian and pancreatic cancer, it’s not a test I would have chosen to take, given the absence of cancer in my family.

“My husband was adopted and wanted to learn more about his genetic makeup, so he selected an online genetics test, 23andMe, and out of curiosity, I decided to join him.”

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Roche's New-Drug Strategy Buoyed by Lung-Cancer Study

Excerpt:

“Swiss drugmaker Roche Holding AG, seeking to expand uses for its drug Tecentriq beyond bladder cancer, said on Thursday a study had shown the new immunotherapy helped people with lung cancer live longer than with chemotherapy.

“The world’s biggest maker of cancer drugs is seeking U.S. Food and Drug Administration approval of Tecentriq for advanced or metastatic non-small cell lung cancer as early as October. It won the regulator’s blessing in May for its use in bladder cancer.

“The FDA has already granted the medicine accelerated review.”

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FDA Submission Completed for Brigatinib in ALK-Positive NSCLC

Excerpt:

“A new drug application (NDA) has been submitted for brigatinib (AP26113) as a potential treatment for patients with advanced ALK-positive non–small cell lung cancer (NSCLC) following resistance or intolerance to crizotinib (Xalkori), according the developer of the ALK inhibitor, Ariad Pharmaceuticals.

“The application was based on findings from the phase II ALTA study, which was presented at the 2016 ASCO Annual Meeting, along with results from an earlier phase I/II trial. In ALTA, the confirmed objective response rate (ORR) for brigatinib at 180 mg daily was 54%, which included a complete response rate of 4%. In those with measurable, active brain metastases treated with the 180 mg dose (n = 18), the intracranial ORR was 67%. Median progression-free survival (PFS) was 12.9 months.”

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Gradalis®, Inc. Announces Dosing of First Patient in Pilot Study Combining Vigil® Engineered Autologous Tumor Cell Immunotherapy and Durvalumab in Advanced Breast Cancer

Excerpt:

“Gradalis®, Inc., a clinical-stage biopharmaceutical company, today announced that the first patient has been dosed in a pilot study combining Vigil® Engineered Autologous Tumor Cells (EATCs) with durvalumab in advanced breast cancer. This is an open-label, investigator-sponsored study supported partly by a grant from Gradalis, to evaluate the safety, tolerability, and efficacy of the combination of Vigil engineered autologous tumor cell immunotherapy and durvalumab (an investigational human monoclonal antibody directed against programmed death ligand-1 (PD-L1)) in patients with no PD-L1 expression and locally advanced or metastatic triple negative breast cancer (TNBC), that have progressed following two prior lines of therapy.”

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Prostate Radiotherapy, ADT May Extend Metastatic Prostate Cancer Survival

Excerpt:

“The addition of prostate radiotherapy to androgen deprivation may prolong survival in men with newly diagnosed metastatic prostate cancer, according to a study published in Journal of Clinical Oncology.

” ‘Prostate radiotherapy represents an attractive local treatment strategy for patients with metastatic prostate cancer, given its noninvasive administration and broad patient candidacy, advancements in delivery allowing for an increasingly favorable toxicity profile, the established role of radiotherapy in the management of locally advanced nonmetastatic prostate cancer, and recent associations between radiotherapy and improved survival for men with lymph node–positive prostate cancer,’ Chad G. Rusthoven, MD, radiation oncologist and assistant professor of radiation oncology at University of Colorado School of Medicine, and colleagues wrote.”

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Is Keytruda Better than Opdivo?

Excerpt:

“Recent clinical trial results are likely to lead doctors to treat more patients who have a common form of lung cancer with a Merck drug at the expense of a Bristol-Myers Squibb medication at least until more data emerges, oncologists and analysts say.

“The yet-to-be-published studies involve drugs in a new class designed to enable the body’s immune system to fight cancer.

“A recent trial of Merck’s Keytruda (pembrolizumab) showed that it worked better than chemotherapy as an initial treatment for advanced non-small cell lung cancer (NSCLC) in patients with high levels of the PDL1 protein, believed to help identify those most likely to benefit from this type of immunotherapy.”

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Cuba's Lung Cancer Vaccine: Hype or Hope?

Excerpt:

“Now that relations between the United States and Cuba are thawing, there has been a growing interest in forming medical partnerships.

“Of particular interest is a lung cancer vaccine called CimaVax, which was developed for non-small cell lung carcinoma. Available in Cuba since 2011, the vaccine has caught the attention of researchers and physicians not only in the United States but in other countries as well.

“But while intriguing, the question remains: Is it really a breakthrough in lung cancer treatment?”

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