The U.S, Senate Feb. 15 voted 50-46 to confirm Robert Califf as the next commissioner of FDA.
FDAÂ granted Fast Track designation for IO-202, a first-in-class myeloid checkpoint inhibitor targeting leukocyte immunoglobulin-like receptor B4 (LILRB4, also known as ILT3) for the treatment of patients with relapsed or refractory acute myeloid leukemia.Â
In a 14:1 vote, ODAC nixes a PD-1 drug developed in China; data not generalizable to U.S. population
The FDA Oncologic Drugs Advisory Committee expressed decisive support for the agency’s view that data from trials of checkpoint inhibitors performed in mainland China aren’t applicable to the U.S. population.
FDA is preparing to review an estimated 25 applications for cancer drugs that are being developed based largely—and in many cases entirely—on data from mainland China.
FDA is investigating a possible increased risk of death with the drug Ukoniq (umbralisib) approved to treat relapsed or refractory marginal zone lymphoma.Â
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.Â
