FDA News

The FDA granted fast track designation to CTX-009 plus paclitaxel for pretreated metastatic or locally advanced biliary tract cancer.

A screening test has been approved by the FDA for adults 45 years of age or older with an average risk for developing colorectal cancer.

Throughout April, the FDA approved drugs for the treatment of diseases including solid tumors, lung cancer, multiple myeloma, bladder cancer, and low-grade glioma.

The FDA has approved tisotumab vedotin-tftv for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

Trastuzumab-strf was approved for HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or GEJ adenocarcinoma.

The FDA approved tovorafenib for certain patients with relapsed or refractory pediatric low-grade glioma.

Lutetium Lu 177 dotatate was approved by the FDA for children aged 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.

Nogapendekin alfa inbakicept-pmln has been approved for use with BCG for the treatment of BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors.

All patients treated with CAR T-cell products are recommended to be monitored life-long for the risk of secondary malignancy, according to the FDA.

Alectinib was approved for the treatment of patients with ALK-positive non-small cell lung cancer after surgical resection.

The optical imaging agent Lumisight and the Lumicell Direct Visualization System received approval from the FDA for fluorescence imaging in breast cancer.

The FDA granted tamibarotene plus azacitidine and venetoclax fast track designation for the treatment of newly diagnosed, unfit, RARA-overexpressed AML.

The FDA’s Oncologic Drugs Advisory Committee voted in favor of minimal residual disease as an end point to support accelerated approval of multiple myeloma treatments.

Cilta-cel (ciltacabtagene autoleucel; Carvykti) was approved by the FDA to treat patients with relapsed or refractory multiple myeloma who have previously received at least one line of therapy.

The FDA granted LSTA1 rare pediatric disease designation for the treatment of osteosarcoma.

The FDA granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu) for patients with unresectable or metastatic HER2-positive solid tumors who have received prior systemic treatment.

The FDA has approved idecabtagene vicleucel for patients with relapsed/refractory multiple myeloma who have received 2 prior lines of therapy.

The biologics license application for datopotamab deruxtecan has been accepted by the FDA for pretreated HR-positive, HER2-negative metastatic breast cancer.

Throughout March, the FDA has approved drugs for the treatment of disease including lung, hematologic, esophageal, and gynecologic cancers.

The new drug application for revumenib is supported by data from the AUGMENT-101 trial of patients with KMT2A-rearranged acute myeloid leukemia or acute lymphoblastic leukemia.

Mirvetuximab soravtansine received full approval from the FDA for pretreated adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.

The safety label for fluorouracil products will now include information about the agent’s use in patients with dihydropyrimidine dehydrogenase deficiency.

Accelerated approval was granted by the FDA to ponatinib plus chemo for adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia.

The Oncologic Drugs Advisory Committee of the FDA unanimously voted in favor of ciltacabtagene autoleucel for the treatment of early relapsed/refractory myeloma.

The FDA granted an orphan drug designation to avutometinib either alone or in combination with defactinib for recurrent low-grade serous ovarian cancer.

The benefits of imetelstat outweigh the risks for anemia treatment in lower-risk myelodysplastic syndrome, according to a vote by the FDA’s Oncologic Drugs Advisory Committee.

Accelerated approval has been granted by the FDA to lisocabtagene maraleucel for the treatment of certain patients with relapsed/refractory CLL or SLL.

Tislelizumab-jsgr (Tevimbra) has been approved for unresectable or metastatic esophageal squamous cell carcinoma (ESCC) among adult patients who have previously received systemic chemotherapy that did not include a PD-1/PD-L1 inhibitor.