The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of Lynparza (olaparib) for the adjuvant treatment of patients with germline BRCA-mutated, HER2-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy.
Indianapolis-based Community Health Network and GRAIL LLC have partnered to offer Galleri, GRAIL’s multi-cancer early detection blood test, to individuals at Community Health Network’s sites of care.
FDA issued a draft guidance, “Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments.”
FDA has granted accelerated approval to Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the treatment of adult and pediatric patients ≥ 6 years of age with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options.
FDA granted Fast Track designation for IK-930, a novel TEAD inhibitor targeting the Hippo signaling pathway, in patients with unresectable NF2-deficient malignant pleural mesothelioma.
Cullinan Oncology Inc. and Taiho Pharmaceutical Co. Ltd. completed their agreement to collaborate on the U.S. development of CLN-081/TAS6417, a next generation, irreversible EGFR inhibitor for the treatment of a genetically defined subset of patients with non-small cell lung cancer (The Cancer Letter, May 13, 2022).
FDA announced it will issue marketing denial orders to all JUUL e-cigarette products. The products must be removed from shelves across the country or risk enforcement action, as FDA has ruled they do not meet the public health standard required to be authorized for sale.
SomaLogic and OncoHost signed a licensing agreement, through which OncoHost will license SomaLogic’s SomaScan Platform to develop proteomics tests for its PROphet diagnostic system, designed to predict patients’ response to immunotherapy treatments and provide strategies to overcome treatment resistance.
The University of Texas MD Anderson Cancer Center, Invectys Inc., and the Cell Therapy Manufacturing Center, a joint venture between MD Anderson and National Resilience Inc., announced a strategic collaboration to jointly develop a process for human leukocyte antigen-G targeted CAR T-cell therapy for solid tumors.
FDA granted Orphan Drug Designation to stage LSD1 inhibitor iadademstat for the treatment of patients with small cell lung cancer.
