Array Walks Back Its FDA Pitch on Binimetinib, Derailing Plans for Commercial Launch

Excerpt:

“Array BioPharma has some explaining to do. Fifteen months after the Boulder, CO-based biotech said that it had the data needed for its first approval of binimetinib for NRAS-positive melanoma, execs are walking back the application and its plans for a launch.

“In a statement out Sunday evening, Array $ARRY said that after getting feedback from the FDA, execs ‘concluded that the clinical benefit demonstrated in the Phase 3 NEMO clinical trial would not be found sufficient to support approval of the NRAS-mutant melanoma NDA.’ ”

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Lilly’s Breast Cancer Drug Combination Succeeds Key Study

Excerpt:

Eli Lilly and Co’s combination of its experimental breast cancer drug and another widely used treatment slowed disease progression in patients who relapsed or did not benefit enough when treated with the anti-estrogen therapy.

“In August, an independent data monitoring committee recommended the late-stage study continue without modification, even though interim evaluation suggested the combination treatment was not delaying cancer progression.

“Lilly’s drug, abemaciclib, is part of the same new class of breast cancer treatments as Pfizer Inc’s Ibrance, and Novartis AG’s newly approved Kisqali.”

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Leading Cancer Organizations: Trump’s Proposed NIH Budget Cuts Will Threaten Research, Patient Care

Excerpt:

“Many of the nation’s leading research organizations and cancer centers have voiced their opposition to President Donald Trump’s proposed budget, which includes a $5.8 billion cut to NIH funding in 2018.

“The budget ‘blueprint’ — released Thursday — proposes $54 billion in cuts overall, including a 16.2% decrease, or $12.6 billion, for the Department of Health and Human Services.”

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ASCO Statement: President’s Budget Will Devastate U.S. Research Enterprise

Excerpt:

“ASCO President Daniel F. Hayes, MD, FACP, FASCO, released the following statement today:

” ‘We soundly oppose President Trump’s budget outline, which would cut $6 billion from the National Institutes of Health (NIH). Reducing NIH’s funding by nearly 20% will devastate our nation’s already-fragile federal research infrastructure and undercut a longstanding commitment to biomedical science that has fueled advances in cancer prevention, diagnosis, and treatment.

” ‘When we are on the cusp of tremendous advances in cancer care, the United States can’t turn back the clock on research that will benefit millions of Americans with life-threatening diseases and their families. Gutting the U.S. research infrastructure won’t make America First, but will decidedly place the United States behind other countries in scientific advances. Failure to nurture the historic U.S. investment in research places health outcomes, scientific leadership, and economic growth at risk.’ ”

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AACR Strongly Opposes the Draconian Cuts to Medical Research Proposed in President Trump’s FY 2018 Budget

Excerpt:

“On behalf of the entire cancer research community, the American Association for Cancer Research (AACR) was shocked to learn that the Trump administration is proposing to cut $5.8 billion from the National Institutes of Health (NIH) budget in fiscal year (FY) 2018.  At a time when extraordinary progress is being made against cancer and many other diseases, these draconian cuts would set research back for decades and also threaten the careers of an entire generation of young investigators working in labs and clinics all over the country who are committed to improving public health and saving lives.”

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Ribociclib Response Unaffected by Prior Treatment

Excerpt:

“The FDA recently approved ribociclib (Kisqali) for use in combination with an aromatase inhibitor as initial therapy for treatment of postmenopausal women with HR+/HER2-negative advanced or metastatic breast cancer.

“Ribociclib, an inhibitor of CDK4/6, was approved based on data from the phase III MONALEESA-2 trial, which was ended early following the first preplanned interim analysis. In this analysis, the combination of ribociclib and the aromatase inhibitor letrozole met the trial’s primary endpoint by demonstrating statistically significant improvement in progression-free survival (PFS) compared to letrozole alone.”

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Expert Discusses Promise of Immunotherapy in TNBC

Excerpt:

“The combination of immunotherapy and chemotherapy is showing promising response rates in certain patients with triple-negative breast cancer (TNBC), said ESO Umberto Veronesi Memorial Award Winner Giuseppe Curigliano, MD, PhD, who addressed genetic determinants of breast cancer immunogenicity in his award lecture at the 15th St. Gallen International Breast Cancer Conference.

“Curigliano emphasized the importance of patient selection in optimizing immunotherapy in breast cancer. In a study done by Curigliano, in collaboration with the Sidra Medical Center in Qatar, a subgroup of patients with TNBC who would derive benefit from checkpoint inhibitors were identified. This group, he stated, should be selected based on individual assessment of tumor-infiltrating lymphocytes.”

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Chemotherapy May Not Be Necessary for Intermediate-Risk, Early-Stage Breast Cancer

Excerpt:

“Women with early-stage breast cancer and an intermediate risk recurrence score from a 21-gene expression assay may be able to avoid chemotherapy, according to a retrospective study published in Cancer.

” ‘Through years of research discoveries, it became clear that we were overtreating many women with breast cancer, especially those with early-stage breast cancer,’ Carlos H. Barcenas, MD, assistant professor of breast medical oncology at The University of Texas MD Anderson Cancer Center, said in a press release. ‘In addition to chemotherapy’s obvious side effects, there were also long-term complications for these women as survivors.’ ”

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Short RT Plus Chemo Benefits Older Brain Cancer Patients

Excerpt:

“Adding temozolomide chemotherapy to short-course radiotherapy for older patients with glioblastoma was tied to longer progression-free and overall survival than with a short course of radiotherapy alone, researchers found.

“In a randomized controlled trial of glioblastoma patients ages 65 and up, those on combination therapy had a significantly lower risk of death during the study than those who had only radiation (HR 0.67, 95% CI 0.56-0.80, P<0.001), James Perry, MD, of Sunnybrook Research Institute in Toronto, and colleagues reported in the New England Journal of Medicine.”

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