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.
Rain Therapeutics Inc. and Roche have entered a clinical supply agreement for the anti-PD-L1 monoclonal antibody Tecentriq (atezolizumab).
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.
The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending approval of Keytruda (pembrolizumab), an anti-PD-1 therapy, as monotherapy for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
Inceptor Bio executed an in-licensing agreement with the University of California, Santa Barbara for an investigational chimeric antigen receptor macrophage (CAR-M) therapy targeting difficult-to-treat tumors.
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.
