FDA News

Ivosidenib, a targeted therapy, has been approved for patients with relapsed or refractory myelodysplastic syndromes and an IDH1 mutation.

The FDA has approved entrectinib to treat pediatric patients ages 1 month and older with NTRK-positive solid tumors.

The FDA has approved tests to identify patients with metastatic non–small cell lung cancer who are eligible for treatment with encorafenib plus binimetinib.

The FDA has granted priority view to osimertinib plus chemotherapy based on data from the phase 3 FLAURA2 trial.

The FDA has approved pembrolizumab with platinum-containing chemotherapy for patients with resectable non–small cell lung cancer, in both the neoadjuvant and adjuvant setting.

The FDA has approved adjuvant nivolumab to treat completely resected stage IIB/C melanoma.

The FDA has approved encorafenib plus binimetinib to treat adults with metastatic non-small cell lung cancer with a BRAF V600E mutation.

The approval of FoundationOne CDx as a companion diagnostic for selpercatinib seeks to broaden access to therapies for patients with RET fusion–positive solid tumors.

The FDA has granted marketing authorization to the Invitae Common Hereditary Cancers Panel, which can detect multiple genetic variants associated with hereditary cancers.

The FDA has approved bosutinib to treat pediatric patients with Philadelphia chromosome–positive, chronic-phase chronic myelogenous leukemia.

The FDA has granted belzutifan priority review designation based on data from the phase 3 LITESPARK-005 trial.

The FDA has approved momelotinib (Ojjaara) for the treatment of adult patients with intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis, and anemia.

The FDA has approved motixafortide in combination with filgrastim to mobilize hematopoietic stem cells in multiple myeloma transplantation, based on findings from the phase 3 GENESIS trial.

The FDA has approved luspatercept to treat anemia in patients with lower-risk myelodysplastic syndromes.

The FDA has granted enzalutamide priority review designation based on data from the phase 3 EMBARK trial.

The FDA has granted ivosidenib priority review designation based on data from a phase 1 trial.

FoundationOne CDx is a next-generation sequencing–based in vitro diagnostic device developed to detect substitutions, insertion, and deletion alterations using 1 tissue sample.

The FDA has approved a liver-directed therapy to treat metastatic uveal melanoma with hepatic metastases.

The FDA has granted accelerated approval to elranatamab-bcmm to treat adults with relapsed or refractory multiple myeloma who have already undergone 4 prior lines of treatment.

The FDA has issued a complete response letter to the new drug application for avasopasem manganese to manage oral mucositis in patients with locally advanced head and neck cancer undergoing radiation.

The FDA has approved niraparib and abiraterone acetate to treat patients with deleterious or suspected deleterious BRCA-positive mCRPC, as detected by an FDA-approved test.

Talquetamab has received accelerated approval for patients with relapsed or refractory multiple myeloma.

The FDA has granted regular approval to pralsetinib as a treatment for adults with metastatic RET fusion-positive non-small cell lung cancer.

The resubmitted biologics license application for remestemcel-L has been issued a complete response letter.

A triplet regimen of trifluridine, tipiracil, and bevacizumab has been approved as a treatment for patients with metastatic colorectal cancer.

The FDA has issued a complete response letter to the biologics license application for denileukin diftitox.

The FDA has approved dostarlimab plus chemotherapy for patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient, as determined by an FDA-approved test, or microsatellite instability-high.

The FDA has approved LeukoStrat CDx FLT3, a companion diagnostic, to help identify patients with FLT3-ITD–positive acute myeloid leukemia who are eligible to receive quizartinib.