FDA Approvals

The US Food and Drug Administration approved datopotamab deruxtecan for the treatment of patients with unresectable or metastatic, HR-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy in...

The FDA granted approval to acalabrutinib with bendamustine and rituximab for patients with previously untreated mantle cell lymphoma ineligible for autologous hematopoietic stem cell transplantation.

On December 20, 2024, the US FDA granted an accelerated approval for encorafenib plus cetuximab and modified FOLFOX6 for patients with metastatic colorectal cancer with a BRAF V600E mutation.

On November 15, 2024, the FDA approved menin inhibitor revumenib for adult and pediatric patients 1 year and older with relapsed/refractory acute leukemia with KMT2A translocation.

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.