Seagen’s Tukysa (tucatinib) has been approved by the European Commission (EC) as part of a triple-combination therapy for people with previously treated advanced or metastatic HER2-positive breast cancer. The EC approved Tukysa, when given alongside trastuzumab and the chemotherapy medication Xeloda (capecitabine), for patients who have received at least two anti-HER2-based treatments for metastatic disease. With this…
Biond Biologics and Sanofi have entered into a worldwide licensing agreement to advance BND-22, a novel immune checkpoint inhibitor, into clinical testing as a potential treatment of solid tumors. An investigational new drug (IND) application, requesting that the treatment be cleared for patient trials, was recently filed with the U.S. Food and Drug Administration. If…
The Israeli Ministry of Health has approved Xpovio (selinexor), in combination with the corticosteroid dexamethasone, for the treatment of people with multiple myeloma who have received three or more prior therapies, and who failed to respond to at least one immunomodulatory agent, one proteasome inhibitor, and one CD38 inhibitor. Xpovio also has won approval in…
The U.S. Food and Drug Administration (FDA) has approved Libtayo (cemiplimab-rwlc), making it the first immunotherapy for people with advanced basal cell carcinoma (BCC) — the most common form of skin cancer — who previously received or were ineligible for treatment with a hedgehog pathway inhibitor. Based on the results of an ongoing Phase 2…
With help from actress Kristen Bell, the Prostate Cancer Foundation (PCF) has opened its 4th annual TRUE Love contest for entries that pay tribute to family members and caregivers of men living with prostate cancer. The organization is seeking caregiving narratives that show love, care, and honor for prostate cancer patients to raise awareness about…
ENB Therapeutics’ lead novel anti-cancer therapy, ENB-003, was found to be safe and showed promising anti-tumor activity, when given in combination with Keytruda (pembrolizumab), to adults with different types of advanced solid malignancies, including ovarian cancer and melanoma. These are the early findings of an open-label Phase 1/2 trial (NCT04205227) that has recently finished dosing…
The first participant has been dosed in the Phase 2 clinical trial TENACITY, which is evaluating Ayala Pharmaceuticals‘ investigational therapy AL101 as a treatment for Notch-activated recurrent or metastatic triple negative breast cancer (TNBC). AL101 is an investigational small molecule that inhibits Notch proteins. This family of cellular proteins plays important roles in governing cell…
Researchers have developed an artificial intelligence (AI) tool that shows the potential to predict prostate cancer aggressiveness and the likelihood of post-surgery relapse more accurately than standard methods can. Called RadClip, for radiomic-clinicopathologic nomogram, the tool was developed by a team from the Center for Computational Imaging and Personalized Diagnostics (CCIPC) at Case Western Reserve…
Heidelberg Pharma has been cleared in the U.S. to begin a clinical trial testing its investigational therapy HDP-101 for the treatment of multiple myeloma. The U.S. Food and Drug Administration (FDA) allowed the start of a Phase 1/2a trial following the submission of an investigational new drug (IND) application. The company expects to enroll the…
The U.S. Food and Drug Administration (FDA) has approved the CAR T-cell therapy Breyanzi (lisocabtagene maraleucel) for treating adults with relapsed or refractory large B-cell lymphoma (LBCL) who have had two or more lines of systemic therapy. The approval covers several types of LBCL: diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising…
