The U.S. Food and Drug Administration (FDA) has granted fast track designation to MEI Pharma‘s investigational compound ME-401 for treating follicular lymphoma patients who received at least two prior therapies. A therapy candidate is put on the FDA’s fast track if it can treat serious conditions and fill an unmet clinical need, either because no treatments…
Category: Cancer
Winners Named for Prostate Cancer Foundation’s TRUE Love Awareness Contest
The 3rd annual TRUE Love Contest of the Prostate Cancer Foundation (PCF), which features inspirational stories from patients and caregivers to raise disease awareness, has selected two winners. Chosen by actress Kristen Bell from more than 100 submitted narratives, the winners are Angie Wilfong of San Antonio, Texas, and Lucy Hayes of Gold Bar, Washington. Wilfong…
CytoDyn Seeks Preliminary FDA Meeting on Leronlimab’s Breakthrough Therapy Status
After a recommendation from the U.S. Food and Drug Administration (FDA), CytoDyn is planning to ask the regulatory agency for a preliminary meeting to discuss the granting of breakthrough therapy status to leronlimab for the treatment of metastatic triple-negative breast cancer (TNBC). Breakthrough therapy designation is intended to accelerate the development, review, and approval of treatments…
Acelarin Trial Shows Potential in Chemo-resistant Ovarian Cancer, But Study Ending
Treatment with Acelarin led to one complete response and two partial responses in heavily pre-treated women with platinum-resistant ovarian cancer, early results from a Phase 2 trial show. Full analysis of the study’s first part is ongoing. However, the treatment’s developer, NuCana, has decided not to continue with a planned second part to focus on trials in other cancers. Acelarin…
FDA Approves Imfinzi-Chemo Combo to Treat Advanced SCLC
The U.S. Food and Drug Administration (FDA) has approved Imfinzi (durvalumab), in combination with standard chemotherapy, as an initial treatment of people with extensive-stage small cell lung cancer (SCLC). This decision was based on findings from the CASPIAN Phase 3 trial (NCT03043872), in which the combination was found to be better than standard chemo alone at extending…
Oncopeptides’ Accelerated Approval Filing for Ygalo in US Unimpeded by COVID-19
Despite some interruptions to Ygalo‘s clinical program due to the ongoing COVID-19 outbreak, Oncopeptides‘ application seeking its accelerated approval in the U.S. for the treatment of triple-refractory multiple myeloma will not be affected, and filing is expected mid-year, the company has announced. “Obviously the COVID-19 pandemic has an enormous impact on us and society as…
Zevalin Improves Survival of Non-Hodgkin’s Lymphoma Patients in Real-world Setting, Study Finds
Treatment with Zevalin (ibritumomab tiuxetan), which combines an antibody with a radioactive agent, was found to be safe, reduced tumor burden in most patients, and significantly improved survival without disease worsening in people with non-Hodgkin’s lymphoma (NHL), a retrospective study reports. The findings were presented during the 2020 American Society of Clinical Oncology and Society for…
Guidelines for Radiation Therapy with COVID-19 Urge Less Treatment
New guidelines for radiation oncologists suggest that, during the COVID-19 pandemic, interactions with healthcare professionals should be done remotely where possible, and treatments should be avoided or delayed to minimize strains on the system and risks to the patient. The guidelines, “Prostate Cancer Radiotherapy Recommendations in Response to COVID-19,” were published in the journal Advances in Radiation…
Tumor Suppressor Neurofibromin Interacts with Estrogen Receptor, Revealing Potential Combo Breast Cancer Therapy
A tumor suppressor protein called neurofibromin, known to block the cancer-inducing Ras pathway, also was found to interact directly with the estrogen receptor (ER) with mutations in this protein leading to treatment resistance in ER-positive breast cancers, a study has revealed. Specifically, cancers lacking a functional neurofibromin protein are resistant to a class of breast…
GEN-1 Added to Chemo Improves Removal of Ovarian Tumors, Early Data Show
The immunotherapy candidate GEN-1 has shown encouraging results in patients newly diagnosed with advanced ovarian cancer, according to initial results of the OVATION 2 study. Adding GEN-1 to neoadjuvant chemotherapy (given before surgery to shrink tumors) increased the proportion of patients with complete removal of their tumors through surgery. GEN-1, developed by Celsion Corporation, consists of…