Noted This Week

July 6–12

Bristol-Myers Squibb announced that the FDA approved nivolumab (Opdivo) plus ipilimumab (Yervoy) for patients ages 12 and older with colorectal cancer who have microsatellite instability–high or mismatch repair–deficient disease and did not respond to fluoropyrimidine, oxaliplatin, and irinotecan. The approval was based on results of the phase II CheckMate-142 trial, in which 119 patients treated with the combination had an overall response rate of 49%, and of those who responded, 83% had a response for least 6 months.

Scientists may be able to predict if individuals are at risk of developing acute myeloid leukemia (AML), according to a study in Nature. Researchers analyzed blood samples from 95 individuals who developed AML and 414 healthy controls and found that those who developed the disease had a greater frequency of mutations in certain genes. The team used this information to create a predictive model that can identify individuals at greater risk.

National and regional governments in Germany will spend almost $98 million to create the LOEWE Centre Frankfurt Cancer Institute following a recommendation by the German Council of Science and Humanities. The institute will be housed on Goethe University’s Niederrad Campus in Frankfurt. “The Frankfurt Cancer Institute...will contribute not only to our scientific understanding of cancer but also to its more targeted treatment,” said Birgitta Wolff, president of Goethe University.

The FDA issued a draft guidance about revamping prescription drug labels. With the document, the agency aims to make labels clearer about the conditions and patient populations drugs are intended to treat, and to reduce clutter from unnecessary information. The FDA will release a final guidance after addressing any concerns raised during the current 60-day comment period.

London, UK–based biomedical research charity Wellcome Trust will devote $330 million to funding high-risk projects through the new Wellcome Leap Fund. “We want to take advantage of the surprising, left-field ideas that pose the question ‘what if?’ and support them in a new way that complements our existing funding structures,” said Wellcome director Jeremy Farrar. The fund will run for 5 years starting in 2020.

The proteasome inhibitor ixazomib (Ninlaro; Takeda) may be an effective adjuvant therapy for patients with multiple myeloma: In the phase III TOURMALINE-MM3 trial, patients who received the drug after responding to high-dose chemotherapy and an autologous stem-cell transplant had significantly longer progression free survival (PFS) than patients who received a placebo. Ixazomib is FDA approved in combination with lenalidomide (Revlimid; Celgene) and dexamethasone as a second-line treatment for the disease.

CTI Biopharma Corp announced that its topoisomerase II inhibitor pixantrone (Pixuvri) in combination with rituximab (MabThera; Roche) did not significantly improve PFS in patients with aggressive B-cell non-Hodgkin lymphoma compared with gemcitabine plus rituximab. The results came in the phase III PIX306 trial of 312 patients who had relapsed after chemotherapy and were not eligible for stem-cell transplant. Pixantrone has conditional approval from the European Union as a monotherapy for relapsed/refractory disease.


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