Oct 23rd, 2021 - The FDA has approved a first-of-its kind continuous delivery system for anti-VEGF therapy for neovascular (wet) age-related macular degeneration (AMD). The Susvimo ocular implant continuously releases 100 mg/mL of ranibizumab directly to the retina over 6 months. Initial implantation and refill can be performed during an office visit with an ophthalmologist. In contrast, conventional intravitre...

Oct 22nd, 2021 - Three medical oncologists at Florida Cancer Specialists & Research Institute (FCS) are co-authors on a new integrated safety analysis of umbralisib, used to treat lymphoid malignancies. FCS Director of Clinical Research Gustavo Fonseca, MD, FACP, Director of Drug Development Manish Patel, MD and James Reeves, MD, a member of the FCS clinical research team, participated in the study entitled Int...

Oct 22nd, 2021 - The immuno-oncology company Agenus has made the decision to withdraw its biologic license application (BLA) for the use of the PD-1 inhibitor balstilimab in patients with recurrent or metastatic cervical cancer who experienced disease progression on, or after, chemotherapy.1 The decision follows the full approval of pembrolizumab (Keytruda) on October 13, 2021, for use as a single agent in pat...

Oct 22nd, 2021 - Low androgen levels appear to be linked to the development of posttransplantation diabetes mellitus (PTDM) in male kidney transplant recipients, new research suggests. London_England/Thinkstock Among 243 men who did not have diabetes prior to undergoing kidney transplantation, levels of both dihydrotestosterone (DHT) and testosterone were inversely related to the risk for developing diabetes th.

Oct 22nd, 2021 - Just months after FDA granted accelerated approval of its myeloma drug, Oncopeptides has pulled melphalan flufenamide (melflufen, Pepaxto) from the market. The decision followed an FDA hold on clinical trials of the drug after data from a confirmatory trial showed an increased mortality risk in patients treated with melflufen. The phase III OCEAN study compared melflufen plus dexamethasone and ...

Oct 22nd, 2021 - The overall incidence of non-small cell lung cancer (NSCLC) decreased from 2010 to 2017, with the incidence of stage IV disease falling, and stage I disease rising, researchers determined. A cross-sectional epidemiological analysis showed that NSCLC incidence per 100,000 population declined from 46.4 to 40.9 during the study period. While the incidence of stage II, IIIA, and IIIB disease was st...

Oct 22nd, 2021 - Clinical advances in the treatment of small cell lung cancer (SCLC) have lagged behind those of other tumor types, but the delay is not for lack of effort. In recent years, however, improved understanding of disease biology has identified some novel targets that may make these tumors more vulnerable to treatment. One such approach in the frontline setting has been the integration of various imm...

Oct 22nd, 2021 - The tyrosine kinase inhibitor (TKI) cabozantinib (Cabometyx) showed promising activity against brain metastases from renal cell carcinoma (RCC), researchers reported. In a retrospective cohort study of 88 patients with RCC brain metastases, the intracranial response rate with cabozantinib was 55% (95% CI 36-73%) in those with progressing brain metastases without concomitant brain-directed local...

Oct 21st, 2021 - Rachna T. Shroff, MD, associate dean, Clinical and Translational Research, associate professor, Medicine in the Clinical Scholar Track, chief, Section of GI Medical Oncology, director, University of Arizona (UA) Cancer Center, director, UA Cancer Center Clinical Trials Office, UA Health Sciences, discusses the importance of targeted therapy in advanced biliary tract cancer. It is an exciting t...

Oct 21st, 2021 - TG-1701 administered as monotherapy or in combination with ublituximab (TGTX-1101) and umbralisib (Ukoniq) demonstrated promising overall response rates (ORR) and with relatively few adverse events (AEs) in patients with chronic lymphocytic leukemia (CLL), according to lead author Chan Cheah, MBBS. He added that the agent is a more specific targeting BTK inhibitor which reduces off-target toxic...

Oct 21st, 2021 - Farrukh Awan, MD: One thing that I always wanted to know was, is there a magic to managing the hypertension? Is there a sequence of drugs that I should use? I know…amlodipine; I know I’m not to use diltiazem. For the β-blockers, I tend to stick with metoprolol because the other one…. Carrie Lenneman, MD, MSCI: Coreg [carvedilol] interacts, yes. Farrukh Awan, MD: Yes, Coreg has an interact...

Oct 21st, 2021 - EVIDENCE SUMMARY General exercise offers benefit …at least for chronic LBP A 2017 systematic review of 4 systematic reviews and 50 RCTs (122 total trials) evaluated general exercise vs usual care for acute (< 4 weeks), subacute (4 to 12 weeks), or chronic (≥ 12 weeks) LBP with or without radiculopathy in adults. 1 Exercise was not consistently associated with decreased pain in acute or subacute.

Oct 21st, 2021 - Investigators have made great strides in the development of radiopharmaceuticals for prostate cancer diagnostics, culminating in recent FDA approvals for the first prostate-specific membrane antigen (PSMA)–targeted radioligands, gallium 68 (68Ga)–PSMA-11 and piflufolastat F 18 (Pylarify), for the detection of disease recurrence and metastatic lesions.1,2 Meanwhile, the use of PSMA-targeted rad...

Oct 21st, 2021 - Adding oral antibiotics to intravenous antibiotics with or without enema came out on top for reducing surgical site infections (SSIs) in patients undergoing elective colorectal surgeries, a network meta-analysis suggested. In the analysis of 35 randomized trials involving over 8,000 patients, this combination had the best probability of ranking first (86% chance) in reducing incisional SSIs, wh...

Oct 21st, 2021 - Fibrolamellar carcinoma is an extremely rare form of liver cancer that affects approximately 1 in 5 million Americans.1 However, because the disease appears so infrequently, it may be underdiagnosed, said Mark Yarchoan, MD. He added that, with an annual age-adjusted incidence rate of just 0.02 per 100,000 in the United States, fibrolamellar carcinoma is so uncommon that investigators have yet t...

Oct 21st, 2021 - There's no denying that the pandemic led to disruptions for research in rare diseases, but the public health crisis did have a "silver lining" for this patient population, NIH investigators said. "COVID-19 came along and it was a little distracting," conceded Matt Hall, PhD, director of the NIH National Center for Advancing Translational Sciences (NCATS) Early Translation Branch, speaking at th...

Oct 21st, 2021 - The FDA approved the digital therapeutic device Luminopia One for pediatric amblyopia, or lazy eye. The device is approved for children ages 4 to 7 years with anisometropia and/or strabismus and is available by prescription only. By means of a virtual reality headset, the device plays therapeutically modified television programs and movies that help correct the vision abnormality. The FDA appro...

Oct 20th, 2021 - Jay Moon Lee, MD, chief, Division of Thoracic Surgery, associate professor of surgery, surgical director, University of California, Los Angeles (UCLA) Thoracic Oncology Program, surgical director, UCLA Center for Esophageal Disorders, member, UCLA Sarcoma Program, Jonsson Comprehensive Cancer Center, UCLA Health, discusses the current state of molecular testing in early-stage non–small cell lun...

Oct 20th, 2021 - Sandip P. Patel, MD, associate professor, University of California, San Diego (UCSD), co-leader, Experimental Therapeutics, deputy director, San Diego Center for Precision Immunotherapy, director, Clinical Trials Office, UCSD Moores Cancer Center, UCSD Health Sciences, discusses the utility of consolidative durvalumab (Imfinzi) in stage III non–small cell lung cancer (NSCLC). The PACIFIC reg...

Oct 20th, 2021 - Key clinical point: Nearly half the patients with uterine fibroids (UF) considered nonresponders to elagolix plus add-back therapy in the 2 phase 3 trials showed a clinically meaningful reduction in menstrual blood loss (MBL). Major finding: Overall, 24% of patients treated with elagolix+add-back therapy were considered nonresponders as they did not meet 1 or more criteria among MBL less than 8.