FDA Approvals, News & Updates
First CAR T-Cell Therapy Unanimously Recommended by FDA Advisory Committee for Treatment of B-Cell ALL in Children and Young Adults
On July 12, 2017, the FDA’s Oncologic Drugs Advisory Committee unanimously recommended the approval of Novartis’s CTL019 (tisagenlecleucel)—the first ever chimeric antigen receptor (CAR) T-cell therapy to be presented to the FDA for review for the treatment of pediatric patients and young adults with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL).
On June 22, 2017, the FDA approved the combination of rituximab and hyaluronidase human (Rituxan Hycela; Genentech) for the treatment of adults with follicular lymphoma, diffuse large B-cell lymphoma (DLBCL), or chronic lymphocytic leukemia (CLL).
Darzalex Combined with Pomalidomide and Dexamethasone Approved for Relapsed/Refractory Multiple Myeloma
On June 16, 2017, the FDA approved daratumumab (Darzalex; Janssen Biotech), in combination with pomalidomide (Pomalyst) and dexamethasone, for the treatment of patients with multiple myeloma who have received at least 2 previous therapies, including lenalidomide (Revlimid) and a proteasome inhibitor.
On May 23, 2017, the FDA granted accelerated approval to pembrolizumab (Keytruda; Merck) for the treatment of metastatic, microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) solid tumors that have progressed after previous treatment and have no appropriate alternative treatments, or for colorectal cancer that has progressed after treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
On May 1, 2017, the FDA accelerated the approval of durvalumab (Imfinzi; AstraZeneca) for the treatment of locally advanced or metastatic urothelial carcinoma in patients whose disease progressed during or after platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment.
On April 28, 2017, the FDA approved brigatinib (Alunbrig; Takeda), an oral kinase inhibitor, for the treatment of patients with metastatic non–small-cell lung cancer (NSCLC) with ALK mutation whose disease progressed during crizotinib therapy or who are intolerant to crizotinib therapy.
On April 28, 2017, midostaurin (Rydapt; Novartis), a kinase inhibitor, became the first targeted therapy, and the first new drug in more than 20 years, to receive FDA approval, in combination with chemotherapy, for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) plus the FLT3 mutation.
On April 17, 2017, atezolizumab (Tecentriq; Genentech), a PD-L1–blocking antibody, received a new indication by the FDA as first-line treatment for patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin chemotherapy.
Page 2 of 6
Results 11 - 20 of 55
Results 11 - 20 of 55