FDA is investigating a possible increased risk of death with the drug Ukoniq (umbralisib) approved to treat relapsed or refractory marginal zone lymphoma.
The Senate Health, Education, Labor, and Pension Committee voted 13-8 to confirm Robert Califf as the next commissioner of FDA. Next, Califf’s candidacy goes to the full Senate.
FDA granted Fast Track designation to the phase III registration program for enobosarm, a selective androgen receptor targeting agonist, for the treatment of androgen receptor positive, estrogen receptor positive, human epidermal growth factor receptor 2 negative (AR+ER+HER2-) metastatic breast cancer patients who have shown previous disease progression on a nonsteroidal AI, Faslodex (fulvestrant), and CDK 4/6 inhibitor therapy, and who have AR% nuclei staining ≥40% in breast cancer tissue (third-line metastatic setting).
FDA has cleared the Investigational New Drug application for P-MUC1C-ALLO1, an allogeneic CAR T-cell product candidate targeting multiple solid tumor indications. The product is sponsored by Poseida Therapeutics.
FDA has granted Breakthrough Therapy designation for CLN-081 for the treatment of patients with locally advanced or metastatic non-small cell lung cancer harboring epidermal growth factor exon 20 insertion mutations who have previously received platinum-based systemic chemotherapy.
FDA has granted Fast Track designation to Reqorsa (quaratusugene ozeplasmid), a pan-kinase inhibitor, plus Keytruda (pembrolizumab) in patients with histologically-confirmed unresectable stage III or IV non-small cell lung cancer whose disease progressed after treatment with Keytruda.
FDA approved Orencia (abatacept) for the prophylaxis of acute graft vs. host disease (aGVHD), in combination with a calcineurin inhibitor (CNI) and methotrexate (MTX), in adults and pediatric patients two years of age and older undergoing hematopoietic stem cell transplantation from a matched or one allele-mismatched unrelated donor.
FDA has approved Rituxan (rituximab) in combination with chemotherapy for pediatric patients (≥6 months to <18 years) with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL), or mature B-cell acute leukemia (B-AL).
FDA approved FoundationOne CDx to be used as a companion diagnostic for two groups of current and future FDA-approved therapeutics in melanoma, including BRAF inhibitor monotherapies targeting BRAFV600E and BRAF/MEK inhibitor combination therapies targeting BRAFV600E or V600K mutations.
FDA has approved Cytalux, a fluorescent imaging agent that binds to cancer cells and allows physicians to identify cancerous lesions during ovarian cancer surgery.
