Jun 23rd, 2022 - DENVER, Colorado — Monoclonal antibodies, antivirals, immunomodulators, and pulmonary arterial vasodilators top the list of drugs that were most frequently implicated as causes of headaches in a federal side effect database that anyone can contribute to, according to a new study presented at the annual meeting of the American Headache Society. Brett Musialowicz "Surprising findings included the...

Jun 23rd, 2022 - The US Food and Drug Administration has granted accelerated approval to dabrafenib (Tafinlar) plus trametinib (Mekinist) for adult and pediatric patients aged 6 years and older with unresectable or metastatic solid tumors with the BRAF V600E mutation whose disease has progressed following prior treatment and who have no satisfactory alternative treatment options. The combination represents "the...

Jun 21st, 2022 - CHICAGO — While the federally supported "Cancer Moonshot" aims to eradicate cancer in the future, back on Earth, a "groundshot" initiative could tackle issues faced by cancer patients right now — both globally and in the US — by making better use of services that are already available. The term "cancer groundshot" was coined in 2016 by Bishal Gyawali, MD, PhD, in a blog post written when he was...

Jun 20th, 2022 - Over the past decade, the US Food and Drug Administration (FDA) has approved new cancer drugs twice as fast as the European Medicines Agency (EMA), often using accelerated pathways, a new analysis shows. Between 2010 and 2019, the FDA approved almost all oncology therapies ahead of the EMA. Drugs entered the US market about 8 months (241 days) before European market authorization. But do quicke...

Jun 17th, 2022 - Globally, colorectal cancer (CRC) ranks as the third leading cancer and the second leading cause of cancer-related death. Estimates suggest that > 1.9 million cases of CRC were diagnosed in 2020; in that same year, 0.9 million deaths were attributed to CRC. The global incidence of CRC is projected to reach 3.2 million in 2040, largely as a result of aging, population growth, and environmental r...

Jun 17th, 2022 - The US Food and Drug Administration (FDA) has approved risankizumab-rzaa (Skyrizi, AbbVie) for a third indication — treatment of moderately to severely active Crohn’s disease in adults — making it the first specific anti-interleukin 23 (IL-23) monoclonal antibody indicated for Crohn’s disease. The safety and efficacy of risankizumab in Crohn’s disease is supported by data from two induction cli...

Jun 15th, 2022 - Use of the targeted therapy combination of venetoclax plus obinutuzumab for fit patients with chronic lymphocytic leukemia (CLL) significantly improved progression-free survival (PFS) at 3 years compared with standard chemoimmunotherapy, new phase 3 data show. Adding the BTK inhibitor ibrutinib to the two-drug combination pushed the 3-year PFS even higher, but the risk of severe adverse events ...

Jun 15th, 2022 - The study covered in this summary was published on researchsquare.com as a preprint and has not yet been peer reviewed. Key Takeaways Whereas an elevated neutrophil-to-lymphocyte ratio has been previously associated with increased risk for mortality in patients with cancer, the current study suggests it is also a predictor of risk for cardiotoxicity from anthracycline therapy in women with brea...

Jun 14th, 2022 - The study covered in this summary was published on ResearchSquare.com as a preprint and has not yet been peer reviewed. Key Takeaway Prophylactic therapy with beta blockers or with dexrazoxane may protect against cardiac dysfunction caused by chemotherapy regimens containing anthracyclines (ANT) or trastuzumab (TZB). Why This Matters ANT and TZB are both effective in the treatment of breast can...

Jun 10th, 2022 - Patients with advanced classical Hodgkin lymphoma treated with first line brentuximab vedotin (Adcetris) plus chemotherapy showed substantial improvements in overall survival compared with those receiving standard chemotherapy, new research shows. Over a follow-up of 6 years, patients on brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine (A+AVD) had a 41% lower risk of death vs ...

Jun 10th, 2022 - NATIONAL HARBOR, Maryland — Ublituximab (TG Therapeutics, Inc), an investigational anti-CD20 monoclonal antibody infused once every 6 months, is effective for treating relapsing forms of multiple sclerosis (RMS), new research suggests. Pooled analysis of the phase 3 ULTIMATE I and II trials, including more than 1000 total patients with RMS, showed significant improvements on several measures of...

Jun 9th, 2022 - NATIONAL HARBOR, Maryland — Evobrutinib, an investigational Bruton's tyrosine kinase (BTK) inhibitor for relapsing multiple sclerosis (RMS), is relatively safe and effective over the long-term, new research suggests. Results from the longest follow-up of any BTK inhibitor drug for MS to-date show efficacy over 2½ years in slowing neurodegeneration in the disease. In addition, "extended experien...

Jun 7th, 2022 - A host of psoriatic arthritis symptoms can be improved by the investigational interleukin (IL)-17 blocker izokibep, according to the results of a phase 2 trial presented at the annual European Congress of Rheumatology. Around half of all participants in the trial who were treated with izokibep achieved a 50% or higher improvement in American College of Rheumatology response criteria (ACR50) at ...

Jun 7th, 2022 - The US Food and Drug Administration (FDA) has approved adding adult patients with rheumatoid arthritis (RA) to the list of indications for the rituximab biosimilar Riabni (rituximab-arrx) on the basis of results of a randomized, double-blind, comparative clinical study with the CD20-directed cytolytic antibody reference product, Rituxan, the biosimilar's manufacturer, Amgen, announced June 6. T...

Jun 6th, 2022 - An antibody drug conjugate that targets a cell-surface antigen found on most breast and bladder cancers demonstrated improved progression-free survival over standard chemotherapy in patients with endocrine-resistant hormone receptor positive/HER2 negative metastatic breast cancer. The agent, called sacituzumab govitecan (Trodelvy, Gilead), was approved on an accelerated basis in 2020 by the Foo...

Jun 6th, 2022 - NATIONAL HARBOR, Md. — Treating neuromyelitis optica spectrum disorder (NMOSD) with the recently approved monoclonal antibody inebilizumab (Uplizna, Horizon Therapeutics) is effective across patient genotypes — including a common genetic variation linked to reduced response to anti-CD20 therapies, new research shows. The phase 3 N-MOmentum Study previously showed safety and efficacy for inebili...

Jun 6th, 2022 - CHICAGO — Breast cancer patients with low levels of HER2 expression, previously considered untreatable with HER2-targeted therapies, benefited from the anti-HER2 antibody drug conjugate trastuzumab deruxtecan. The therapy doubled progression-free survival versus chemotherapy in patients with hormone receptor positive (HR+) and low levels of HER2. "Overall, these results establish HER2 low metas...

Jun 5th, 2022 - A suspicion from retrospective data has now been confirmed by a prospective clinical trial: adding panitumumab (Vectibix) to standard chemotherapy in left-sided RAS wild-type metastatic colorectal cancer (mCRC) is more effective than adding bevacizumab (Avastin). Patients treated with panitumumab alongside chemotherapy saw a 16% improvement in overall survival versus those given bevacizumab aft...

Jun 4th, 2022 - Dr Michael Wang The largest trial to date in mantle cell lymphoma shows that adding the Bruton's tyrosine kinase (BTK) inhibitor ibrutinib (Imbruvica) to standard of care treatment improves progression-free survival (PFS) by 50%. The phase 3 SHINE study was conducted in 520 older patients (aged ≥ 65 years) with newly diagnosed mantle cell lymphoma who were randomized to receive ibrutinib or pla...

Jun 4th, 2022 - An investigational agent has shown promise in a subgroup of patients with advanced pancreatic cancer, offering hope of a clinical advance in a cancer that remains very difficult to treat.  The drug is nimotuzumab, developed as a joint Chinese–Cuban venture, a monoclonal antibody that targets the epidermal growth factor receptor (EGFR), inhibiting tumor cells that overexpress EGFR. When nimotuzu...