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OBR Oncology
During its April 28 meeting, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 11-1 on whether access to the combination should be limited to patients whose tumors carry BRCA mutations. The majority of members shared the FDA reviewers’ concerns regarding clinical trial results and uncertainty about whether people without the BRCA mutation would benefit from the regimen. The FDA argued that the results of the phase 3 PROpel clinical trial could not be applied to patients who had not had their BRCA or HRR mutation status determined. As a result, the FDA contended that the PROpel intention-to-treat (ITT) group was heterogeneous, complicating the interpretation and application of the trial’s results to unselected patients.
Oncology, Medical May 8th 2023
Hemophilia News Today
The business launched a precautionary global recall of desmopressin formulations used to treat mild-to-moderate hemophilia A and von Willebrand disease after higher-than-specified amounts of desmopressin were discovered in various formulations. Stimate, a nasal spray containing a synthetic form of desmopressin acetate used to control bleeding in hemophilia patients, is among the recalled products, as is Octostim Nasal Spray 1.5 mg/ml, DDAVP 10 micrograms (mcg)/0.1 ml, Minirin Nasal Spray 0.1 mg/ml, and Generic Desmopressin Acetate Nasal Spray 10 mcg/0.1 ml. Products containing higher-than-specified amounts of desmopressin were recalled due to concerns that increased desmopressin exposure can result in water retention, low blood pressure, and low blood salt levels in mild cases, as well as seizure, coma, and death.
Hematology May 8th 2023
MDLinx
According to surveys, up to 40% of cancer patients in the United States use cannabis, yet only one-third of doctors are comfortable advising them on it. Now, a small but significant study has found that cancer patients who use cannabis to treat their symptoms had reduced pain, better sleep, and an unexpected benefit: they appear to think more clearly after a few weeks of consistent use. The study, published in the journal Exploration in Medicine, is one of the first to look at how cannabis purchased via dispensaries, rather than government-supplied or synthetic kinds, affects cancer symptoms or chemotherapy side effects. It also sheds light on the large range of drugs used by cancer patients now that marijuana is legal in the majority of states.
JAMA Network
From November 15, 2015, to March 9, 2021, scientists conducted an open-label, phase 3 randomized clinical trial at 17 Spanish centers to assess the efficacy and safety of intraoperative HIPEC in patients with locally advanced colon cancer. The primary outcome was the 3-year locoregional control (LC) rate, which was defined as the proportion of patients who did not have peritoneal disease recurrence after adjusting for intention to treat. Patients included ranged in age from 18 to 75 years old and had been diagnosed with locally advanced primary colon cancer prior to surgery. They discovered that combining HIPEC with complete surgical resection for locally advanced colon cancer enhanced the 3-year LC rate compared to surgery alone, and they recommend that this strategy be evaluated for patients with locally advanced colorectal cancer.
The New England Journal of Medicine
Temporary suspension of endocrine medication to seek pregnancy did not give a higher short-term risk of breast cancer events, including distant recurrence, than the external control cohort among select women with previous hormone receptor-positive (HR+) early breast cancer. Further investigation is required to ensure long-term safety.
The recent acquisition of OneOncology by AmerisourceBergen Corporation and TPG Capital highlights the potential for private equity to support and grow community oncology care across the United States. Private equity firms are seeing opportunities in oncology, as they could help slow or reverse the trend of hospitals consolidating practices by providing significant funding needed upfront to start and operate a community oncology practice. With all the changing insurance relationships and the cost of doing business on a day-to-day basis, that’s a pretty risky proposition. But if private equity firms provide capital support, then it’s somebody else’s financial risk. OneOncology is a management services organization that partners with community oncology practices to provide resources that help institutions improve care and remain sustainable as the reimbursement environment changes. Its services provide “shelter in the storm,” especially with value-based care. Many practices are entering into reimbursement models in which they are taking on downside-risk, being part of OneOncology’s network allows them to spread and minimize potential financial loss. The uniqueness of this model is that it supports practices while keeping the operational decision-making at the practice-level independent. The recent acquisition of OneOncology is further proof that OneOncology’s mission is receiving greater support, and […]