FDA News

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 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.

Quizartinib has been approved by the FDA for use with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy after consolidation chemotherapy, to treat adults with newly diagnosed acute myeloid leukemia that is FLT3-ITD positive, as detected by an FDA-approved test.

The FDA has granted priority review to the biologics license application for zolbetuximab as a treatment for patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.

The FDA has approved a ready-to-dilute cyclophosphamide injection.

Manufacturers are pulling the pralsetinib indication for patients with medullary thyroid cancer. It is still under investigation as a treatment option for patients with non–small cell lung cancer.

The FDA has launched a priority review of capivasertib and fulvestrant based on data from the phase 3 CAPItello-291 trial.

The FDA has launched a priority review of lifileucel based on data from the phase 2 C-144-01 trial.

Natasha Kormanik MSN, CRNP, FNP-BC, OCN, discusses accelerated vs regular approvals in hematologic oncology and how it applies to approved PI3K inhibitors.

The FDA has launched a priority review of repotrectinib based on data from the phase 1/2 TRIDENT-trial.

The FDA has launched a priority review of fruquintinib as treatment for adult patients with previously treated metastatic colorectal cancer.

The FDA has granted blinatumomab full approval for patients with minimal residual disease–positive B-cell acute lymphoblastic leukemia.

The PARP inhibitor talazoparib has been approved in combination with enzalutamide for the treatment of adult patients with homologous recombination repair gene–mutated metastatic castration-resistant prostate cancer.

Glofitamab has received accelerated approval for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, or large B-cell lymphoma arising from follicular lymphoma.

The FDA has approved olaparib for patients with BRCA-positive metastatic castration-resistant prostate cancer (mCRPC), as determined by an FDA-approved companion diagnostic test.

The PET diagnostic imaging agent, flotufolastat F 18 injection has been approved by the FDA for the identification of prostate-specific membrane antigen–positive lesions in men with prostate cancer

The FDA has granted priority review status to a breast cancer optical imaging agent, Lumisight.

The FDA has approved avapritinib for the treatment of patients with indolent systemic mastocytosis.

The FDA has issued a complete response letter for vic-trastuzumab duocarmazine.