FDA Approvals

On November 8, 2024, the FDA approved CD19-directed genetically modified autologous T cell immunotherapy obecabtagene autoleucel for the treatment of patients with relapsed/refractory B-cell precursor acute lymphoblastic leukemia.

The FDA granted accelerated approval to asciminib for patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase.

Based on results from the SPOTLIGHT and GLOW trials, the FDA has approved first-line zolbetuximab plus fluoropyrimidine and platinum-containing chemotherapy for patients with locally advanced, unresectable, or metastatic HER2-negative gastric...

On October 15, 2024, the FDA granted approval to the Optune Lua, a wearable device that delivers Tumor Treating Fields, for treatment of patients with metastatic non-small cell lung cancer.

The FDA has approved inavolisib, with palbociclib and fulvestrant for patients with endocrine-resistant, PIK3CA-mutated HR-positive, HER2-negative locally advanced or metastatic breast cancer.

Based on results from the BLUE-C study, the FDA has approved the Cologuard Plus™ test for patients 45 years and older at average risk for colorectal cancer.

Based on results from the CHECKMATE-77T trial, the FDA has approved nivolumab plus platinum-doublet chemotherapy followed by surgical resection and single-agent nivolumab for patients with non-small cell lung cancer with no known EGFR...

Based on results from the phase 3 LIBRETTO-531 study, the FDA has granted traditional approval to selpercatinib for adult and pediatric patients 2 years and older with advanced or metastatic medullary thyroid cancer harboring a RET mutation.

The US Food and Drug Administration granted approval to isatuximab with bortezomib, lenalidomide, and dexamethasone for the frontline treatment of patients with multiple myeloma who are not eligible for autologous stem cell transplant.

The FDA approved amivantamab plus carboplatin and pemetrexed for patients with locally advanced or metastatic non-small cell lung cancer with EGFR exon 19 deletions or exon 21 L858R substitution mutations and disease progression on or...