The European Commission has conditionally approved Enhertu (trastuzumab deruxtecan) for adults in the EU with inoperable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens. A conditional approval is granted when the benefits of a medication regulators say still requires additional data or testing are found to outweigh its potential…
Conditions
Conditions
Retifanlimab Under FDA Priority Review for Advanced Anal Canal Cancer
Retifanlimab is under review in the U.S. as a treatment for advanced squamous cell carcinoma of the anal canal (SCAC), a rare cancer of the digestive system, in adults who are unable to receive, or whose disease progressed after, initial platinum-based chemotherapy. Incyte’s biologics licence application (BLA) to the U.S. Food and Drug Administration (FDA)…
$10M Gift to Open Myeloma Research Center at Ohio State
A new research center at Ohio State University (OSU) aims to speed work into the discovery and development of more effective treatments for those with multiple myeloma. The Riney Family Foundation Myeloma Center for Advanced Research Excellence (Myeloma CARE) is being established through a $10 million gift from the Paula and Rodger Riney Foundation to the…
EPI-7386 Combo Therapies Enter Trial for Certain mCRPC Patients
Essa Pharma has entered a clinical collaboration with Janssen to evaluate its small molecule inhibitor EPI-7386, in combination with either Erleada (apalutamide) or Zytiga (abiraterone acetate) plus prednisone, for patients with metastatic castration-resistant prostate cancer (mCRPC). Under the terms of the agreement, Janssen will conduct up to two Phase 1/2 clinical trials evaluating these combinations in…
Patients, Caregivers Urged to Get COVID-19 Vaccines ASAP
People with Alzheimer’s disease, as well as their caregivers, are being urged — on social media and via press releases — to get COVID-19 vaccines as soon as possible. That’s the recommendation of the Medical, Scientific and Memory Screening Advisory Board of the Alzheimer’s Foundation of America (AFA). “Getting vaccinated is one of the most…
Combining Imaging Methods May Reduce Need for Tumor Biopsies
Combining two imaging methods can provide a more accurate sampling of single tumors — like those found in ovarian cancer — thus allowing doctors to capture the diverse cancer cells in the tumor with fewer biopsies, a new study found. The study, “Ultrasound-guided targeted biopsies of CT-based radiomic tumour habitats: technical development and initial experience…
Nonprofit Highlights Importance of Global Teamwork for World Cancer Day
In honor of World Cancer Day on Feb. 4, the Breast International Group (BIG) emphasized the importance of wide-scale cooperation in efforts to advance cancer research. “None of BIG’s achievements would be possible without the willingness to work together,” stated a press release highlighting some of the clinical trials that are supported by BIG, an…
Bavencio Approved in EU as First-line Maintenance Therapy for Bladder Cancer
The European Commission (EC) has approved Bavencio (avelumab) as a first-line maintenance treatment for adults with advanced urothelial carcinoma, the most common form of bladder cancer, whose disease did not progress after platinum-based chemotherapy. This decision follows a positive recommendation from the Committee for Medicinal Products for Human Use, a branch of the European Medicines Agency. Bavencio…
Jakafi Plus Steroid Continuing to Treat Multiple Myeloma in Phase 1 Trial
Combining the corticosteroid methylprednisolone and Jakafi (ruxolitinib), an approved oral therapy for bone marrow disorders, is showing promising effectiveness in heavily pre-treated multiple myeloma patients in an ongoing Phase 1 trial. Findings to date from this open-label study (NCT03110822), which is being sponsored by Onco Therapeutics, showed that the combination not only elicited promising responses but was…
Biological Clock Protein CRY-1 Eyed as Therapeutic Target
CRY-1, a regulator of our circadian clocks, contributes to disease spread and poor outcomes in prostate cancer patients by boosting DNA repair mechanisms that render cells more resistant to treatments, a study reveals. The findings support further investigation of CRY-1 as a therapeutic target, especially in prostate cancers that fail to respond to current therapies. The…
EU Approves Keytruda as First-line Treatment for Certain Colorectal Cancers
The European Commission has approved Keytruda (pembrolizumab) as a first-line therapy for adults with metastatic colorectal cancer whose tumors have certain genetic features, the company announced. The genetic features, according to a press release, include microsatellite instability-high (MSI-H) and deficient mismatch repair (dMMR), both good indicators that tumor cells have impaired DNA repair. These DNA repair deficiencies contribute…
Dosing Begins in Phase 1 Trial of CERC-007
Cerecor has dosed the first patient in a Phase 1b clinical trial evaluating CERC-007 as a potential treatment for relapsed or refractory multiple myeloma. The trial (NCT04671251) intends to enroll up to 30 adult patients who received prior treatment with a proteasome inhibitor, an immunomodulatory agent, and a CD38 inhibitor. Recruitment is ongoing at four…