FDA News

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.

Fast track designation has been granted by the FDA to PT217 for extensive stage small cell lung cancer with disease progression.

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.

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.

In a 16-to-2 vote, the FDA's Medical Imaging Drugs Advisory Committee voted in support of the benefit-risk profile of Lumisight to detect cancerous tissue during breast conservation surgery.

A biologics license application has been accepted by the FDA for first-line tislelizumab plus chemotherapy for gastric/gastroesophageal junction cancer.

The FDA approved zanubrutinib plus obinutuzumab for the treatment of patients with relapsed or refractory follicular lymphoma after receiving 2 or more lines of systemic therapy.

Nivolumab plus cisplatin and gemcitabine received FDA approval for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.

The antibody-drug conjugate inotuzumab ozogamicin was approved by the FDA for the treatment of patients aged 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia.